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The CERENOVUS Large Bore Catheter, with the CERENOVUS® Aspiration Tubing Set and NOUVAG Vacuson 60 aspiration pump (or equivalent aspiration pump), is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA are candidates for treatment. The CERENOVUS® Aspiration Tubing Set is intended to connect the CERENOVUS Large Bore Catheter to the canister of the NOUVAG Vacuson 60 Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow.

The CERENOVUS Large Bore Catheter is a variable stiffness, single lumen catheter designed to be introduced over a steerable guide wire or microcatheter into the neuro vasculature. The catheter shaft is composed of a stainless steel variable pitch braid with a PTFE inner liner to facilitate movement of guide wires and other devices. The exterior of the catheter shaft is covered with polymer materials, which encapsulate the stainless steel braid construction. The catheter has a stiff proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The distal end of the catheter has a radiopaque marker band to facilitate fluoroscopic visualization and has a hydrophilic coating to provide lubricity for navigation of vessels. The proximal end of the catheter has a luer fitting located on the end of the catheter hub which can be used to attach accessories for flushing and aspiration. An ID band is placed at the distal end of the hub over a strain relief. The catheter is packaged with a hemostasis valve with a side port and two peel-away introducers as accessories. The hemostasis valve with side port is used for flushing, insertion of catheters, and connection to an external aspiration system. The peel away introducer sheaths are designed to protect the distal tip of the catheter during insertion into the hemostasis valve. The CERENOVUS Large Bore Catheter can be connected to the NOUVAG Vacuson 60 aspiration pump (or equivalent aspiration pump) using the CERENOVUS® Aspiration Tubing Set.

The CERENOVUS Large Bore Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The CERENOVUS Large Bore Catheter is also indicated for use as a conduit for retrieval devices.

The CERENOVUS Large Bore Catheter is a variable stiffness, single lumen catheter designed to be introduced over a steerable guide wire or microcatheter into the neuro vasculature. The catheter shaft is composed of a stainless steel variable pitch braid with a PTFE inner liner to facilitate movement of guide wires and other devices. The exterior of the catheter shaft is covered with polymer materials, which encapsulate the stainless steel braid construction. The catheter has a stiff proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The distal end of the catheter has a radiopague marker band to facilitate fluoroscopic visualization and has a hydrophilic coating to provide lubricity for navigation of vessels. The proximal end of the catheter has a luer fitting located on the end of the catheter hub. An ID band is placed at the distal end of the hub over a strain relief. The catheter is packaged with a hemostasis valve with a side port and two peel-away introducers as accessories. The hemostasis valve with side port is used for flushing and insertion of catheters. The peel away introducer sheaths are designed to protect the distal tip of the catheter during insertion into the hemostasis valve.

CereLink ICP Sensor Basic Kit (82-6850); CereLink ICP Sensor Metal Skull (82-6851); CereLink ICP Sensor Plastic Skull (82-6852) Indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only. CereLink ICP Sensor Ventricular Catheter Kit (82-6854) Indicated when direct intraventricular pressure monitoring is required. The kit is indicated for use in ICP monitoring and cerebrospinal fluid (CSF) drainage applications

The CereLink ICP Sensor Kits are used to monitor intracranial pressure (ICP) through either a stand-alone probe, or a probe coupled with an External Ventricular Drainage (EVD) catheter. The probe, also known as the CereLink ICP Sensor is intended to be used in conjunction with all of Codman's neuromonitoring devices: the Codman ICP Express Monitor (product code 82-6634) and the DirectLink ICP Module (product code 82-6828). The ICP Express and DirectLink are intended for use in ICUs. The CereLink ICP Sensor converts the pressure sensor to a voltage signal. The monitor provides power to the sensor, interprets the voltage signal from the sensor, and displays the corresponding pressure measurements taken by the sensor during a patient's treatment and during patient transport. There is no change to the currently marketed Codman ICP Express or DirectLink as a result of the probe modifications described in this submission. The CereLink ICP Sensor contains a small, thin pressure sensor used to measure the intracranial pressure. The sensing element uses a strain gauge located at the tip of the probe. The sensing element is protected by a titanium housing and is exposed to the environment via a silicone membrane. The sensor is connected via wires to a plastic connector housing, and the wires are snaked through a nylon catheter. The connector housing includes a compensation/calibration passive circuit on a Printed Circuit Board (PCB). Additionally, the CereLink ICP Sensor's connector housing includes a new memory PCB board. When the CereLink ICP Sensor is used with either the ICP Express or DirectLink, it functions identically to the cleared predicate Codman Microsensors. Additionally, the connector housing has an electrical connector to attach to any of the monitoring devices. The CereLink ICP Sensor Kits include components needed to facilitate the surgical implantation of the Cerelink ICP sensor. The components that will be included with the proposed CereLink ICP Sensor Kits are currently cleared devices, and are identical to the components currently packaged within the predicate Codman Microsensor Kits (i.e. there are no changes being made to the kit components, only the ICP sensor is being modified). Each component and their function are described in the Description section of the Instructions for Use for each kit.

Use of the CODMAN EDS 3 CSF External Drainage System (EDS 3) is indicated for draining cerebrospinal fluid (CSF) from the cerebral ventricles or the lumbar subarachnoid space as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated. Use the External Drainage System Collection Bag with the CODMAN EDS 3 External Drainage System to measure and collect cerebrospinal fluid (CSF).

The Codman EDS 3 CSF External Drainage System (Codman EDS 3 System) is designed to drain cerebral spinal fluid (CSF) at a controlled rate based on differential pressure between the device and the patient. Collecting CSF from the patient is performed in efforts to reduce elevated intracranial pressure (ICP) post trauma. The EDS 3 device is comprised of four (4) main parts: ventricular catheter, patient drain line, base frame drip chamber assembly, and a collection bag. Note: The collection bag is sold as part of the Codman EDS 3 System, as well as sold separately. The principle of operation of the proposed Codman EDS 3 system is identical to the currently marketed Codman EDS 3 system. The ventricular catheter is placed into one of the ventricles in the brain or in the subarachnoid space and is then connected to the patient drainage line. CSF flows from the brain or lumbar region through the patient line and enters into the 100 mL graduated drip chamber assembly, where it is collected over a period of time to calculate a flow rate. The drip chamber assembly can then be raised or lowered along the base frame, thereby adjusting the differential pressure to achieve the appropriate flow rate. Once the drip chamber height is set, the collected CSF is then drained into the attached 700 mL collection bag. The Codman EDS 3 CSF External Drainage System Collection Bag is a sterile, vented 700 mL capacity bag that is graduated in 50 mL increments for accurate measurement. A microbial-retentive atmospheric vent facilitates CSF flow into the bag. One bag is provided with the system and replacement bags are sold separately as an accessory to the drain. The EDS 3 system is a complete, disposable unit that is provided sterile and is available with or without a ventricular catheter.

The Codman HAKIM Precision Valve System is an implantable device that provides constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus. The Codman HAKIM Programmable Valve System is an implantable device that provides constant intraventricular pressure and drainages of cerebral spinal fluid (CSF) for the management of hydrocephalus. The Codman HOLTER Lumboperitoneal (LP) Shunt is indicated for shunting cerebrospinal fluid when the lumboperitoneal route is the procedure of choice in the treatment of communicating hydrocephalus. The Codman HOLTER Atrial Catheters are indicated for use to shunt cerebrospinal fluid, when shunting of cerebrospinal fluid to the atrium is the procedure of choice in the treatment of hydrocephalus. The Codman HOLTER Ventricular Catheters are indicated for use to gain access to the ventricles for diagnostic purposes and in the treatment of hydrocephalus. The Codman Medos Ventricular Catheter is indicated for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated. The UNI-SHUNT System is indicated for use as a one-piece ventriculo-peritoneal shunt system for the palliative treatment of hydrocephalus. No other use is recommended. The Codman BACTISEAL Catheters are indicated for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

Codman HAKIM Precision and Programmable Valves: The Codman HAKIM Precision and Programmable Valves are implantable devices that provide constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus. Both the Codman HAKIM Precision and Programmable Valves are pressure regulating valves which maintain intraventricular pressure at a constant level. The Codman HAKIM Precision valves are fixed pressure valves and are available in 5 different opening pressure ranges. The Codman HAKIM Programmable Valves, not having fixed pressures, permit non-invasive adjustment of the valve opening pressure. The Codman HAKIM Programmable Valves can be adjusted to 18 different opening pressure settings. Codman HOLTER Catheters: The HOLTER Catheter, is a barium-impregnated silicone rubber open-ended catheter. Two stainless steel Type "A" Fixation and Joining Connectors are included with each catheter to use in rejoining the catheter if it has been cut for lengthening or revision. The HOLTER Catheter, Salmon Design, is a barium-impregnated silicone rubber catheter. Four longitudinal slits (90° apart) near the closed distal tip of the catheter are for drainage of cerebrospinal fluid. Two stainless steel Type "A" Connectors are included with each catheter to use in rejoining the catheter if it has been cut for lengthening or revision. Codman Medos Ventricular Catheter: The Medos Ventricular Catheter is made from barium-impregnated silicone tubing. The catheter is 140 mm in length and is supplied with 24 inlet holes, 3 rows of 8 holes, at the proximal end. The catheter, with stainless steel stylet and right angle adapter, is supplied sterile. UNI-SHUNT® System: The UNI-SHUNT® system with Reservoir incorporates a double dome access port to facilitate injections and aspirations of CSF samples. It is a continuous length of barium-impregnated silicone tubing with an access reservoir made of self-sealing silicone which can be punctured with a 25 gauge or smaller Huber type needle. Codman BACTISEAL Catheters: The BACTISEAL Catheters are made of radiopaque (barium-impregnated) silicone tubing and are supplied sterile. BACTISEAL Catheters are subjected to a treatment process by which the silicone tubing is impregnated with rifampin and clindamycin hydrochloride. The catheter is 14 cm in length and is supplied with 24 inlet holes (3 rows of 8 holes) at the proximal end. Depth marks have been added to the catheter (one dot at 5 cm and two dots at 10 cm). A stainless-steel stylet and right angle adapter are packaged with the ventricular catheter. The peritoneal catheter has a beveled tip at one end and the other end of the catheter has a flat tip. The catheter is 120 cm long and may be trimmed to the proper length.

The GALAXY G3 Mini Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.

The GALAXY G3 Mini Microcoil Delivery Systems consist of three components, a Microcoil System, a connecting cable, and a Detachment Control Box (DCB). Each component is sold separately. As shown in Figure 1, the Microcoil System consists of a microcoil attached to a Device Positioning Unit (DPU). The Microcoil System is packaged in an introducer sheath designed to protect the coil in the packaging dispenser and to provide support for introducing the coil into the microcatheter catheter. The microcoil is the implantable segment of the device, and is detached from the Device Positioning Unit (DPU) using the Detachment Control System (Detachment Control Box and connecting cable). The microcoil is fabricated from a platinum alloy wire. The wire is wound into a primary coil which contains a polypropylene suture (SR) and then formed into a secondary shape. The secondary shape is complex. The DPU is a variable stiffness wire and has a radiopaque marker band located three (3) cm from its distal end. The Device Positioning Unit includes five (5) fluoro saver markers on the proximal section of the shaft. The markers are intended to indicate when the tip of the microcoil is approaching the tip of the microcatheter. When the distal-most marker reaches the proximal end of the Rotating Hemostatic Valve (RHV) on the microcatheter, the tip of the coil is approaching the tip of the microcatheter and fluoroscopy should be used to guide further coil insertion. The introducer sheath has three main components: an introducer tip, a translucent introducer body, and a re-sheathing tool. The EnPOWER Detachment Control Box (DCB) provides the energy necessary to allow for a thermo-mechanical detachment of the microcoil from the DPU. The connecting cable delivers the energy necessary to detach the embolic coil from the Microcoil System's detachment zone. The connecting cable is connected between the Microcoil System's hub connector on the DPU and the output connector on the DCB. The connecting cables may be one of two types: one with a remote detach button (the EnPower Control Cable) catalog no. ECB000182-00, or one without a detach button (standard connecting cable) catalog no. CCB00157-00. The EnPower Detachment Control Box works with the EnPower Control Cable and with the standard connecting cable.

MICRUSFRAME, DELTAFILL, and DELTAXSFT Microcoil Delivery Systems are intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for arterial and venous embolizations in the peripheral vasculature. The GALAXY G3 FILL Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and is also intended for arterial and venous embolizations in the peripheral vasculature. The GALAXY G3 XSFT Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

The MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3 FILL, GALAXY G3 XSFT Microcoil Delivery Systems consist of three components, a Microcoil System, a connecting cable, and a Detachment Control Box (DCB). Each component is sold separately. As shown in Figure 1, the Microcoil System consists of a microcoil attached to a Device Positioning Unit (DPU). The Microcoil System is packaged in an introducer sheath designed to protect the coil in the packaging dispenser and to provide support for introducing the coil into the microcatheter catheter. The microcoil is the implantable segment of the device, and is detached from the Device Positioning Unit (DPU) using the Detachment Control System (Detachment Control Box and connecting cable). The devices in this submission include minor design changes only to the Device Positioning Unit's introducer sheath (introducer). There are no modifications to components or materials of the micro-coil or the ENPOWER Detachment Control System. Minor dimensional and design modifications to the introducer will help improve deliverability of the micro-coils.

The YOGA Microcatheter is intended for use in peripheral, coronary, and neuro vasculature for the intravascular introduction of interventional/diagnostic devices.

The YOGA Microcatheter is a variable stiffness, single lumen catheter designed to access small, tortuous vasculature. The catheter shaft is composed of a variable pitch stainless steel braid with a PTFE inner liner to facilitate movement of guide wires and other devices. The exterior of the catheter shaft is covered with a polymer material, which encapsulates the stainless steel braid construction. The distal end of the catheter has a radiopaque marker band and has a hydrophilic coating to provide lubricity for navigation of vessels. The proximal end of the catheter has a hub and an ID band is placed at the distal end of the hub over a strain relief. A steam shaping mandrel is provided in the package. The two new YOGA Microcatheters are provided in back up (XB) and extra backup (XXB) configurations, i.e. a stiffer distal end to provide additional support.

The YOGA Microcatheter is intended for use in the peripheral, coronary, and neuro vasculature for the intravascular introduction of interventional/diagnostic devices.

The YOGA Microcatheter is a variable stiffness, end to end braided single lumen catheter designed to access small, tortuous vasculature. The microcatheter has an outer hydrophilic coating that provides lubricity during navigation of vessels. The lubricious PTFE lined inner lumen is designed to facilitate movement of guide wires and other devices. A radiopaque marker band is provided at the catheter tip to aid fluoroscopic visualization. A luer fitting located on the proximal end of the catheter hub is used to attach accessories. A steam shaping mandrel is provided in the package.

Use of the Codman EDS3 CSF External Drainage System is indicated for draining cerebrospinal fluid (CSF) from the cerebral ventricles or the lumbar subarachnoid space as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated.

The Codman EDS3 CSF External Drainage System (Codman EDS3 System) is designed to collect cerebral spinal fluid (CSF) from the patient at a controlled rate based on differential pressure between the device and the patient. Collecting CSF from the patient is performed in efforts to reduce elevated intracranial pressure (ICP) post trauma. The EDS3 device is comprised of four (4) main parts: ventricular catheter, patient drain line, base frame burette tube assembly and a collection bag. The ventricular catheter is placed into one of the ventricles in the brain or in the subarachnoid space and is then connected to the patient drainage line. CSF flows from the brain through the patient line and enters into the 100 mL graduated burette tube assembly, where it is collected over a period of time to calculate a flow rate. The burette tube assembly can then be raised or lowered along the base frame, thereby adjusting the differential pressure to achieve the appropriate flow rate. Once the burette tube height is set, the collected CSF is then drained into the attached 700 ml collection bag. The EDS3 System is a complete, disposable unit that is provided sterile and is available with or without a ventricular catheter.