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The Codman Disposable Perforator is for use in perforating the cranium. When properly used, it is designed to automatically disengage once perforation is accomplished and when pressure is removed from the drill point.

The Codman Disposable Perforators are pre-assembled, single-use, sterile devices that are designed to perforate the cranium. When properly used, the Disposable Perforators are designed to automatically disengage once perforation is accomplished and when pressure is removed from the drill point. They are designed with a Hudson end and are available in three color-coded sizes: - 14mm (blue ABS sleeve) – product number: 26-1221 - 11mm (green ABS sleeve) product number: 26-1222 ● - 9mm (yellow ABS sleeve) product number: 26-1223 ●

The ICP Monitor is intended for use as an interface between compatible strain gauge type pressure transducers and standard physiological pressure monitoring systems. The ICP Monitor is also intended for use as an independent pressure monitor for displaying the mean, systolic and diastolic values of a physiologic pressure waveform in the absence of an external patient monitor. The CereLink ICP Extension Cable is intended for use as a connecting cable between the ICP input channel of the CereLink ICP Monitor and a CereLink ICP Sensor.

The CereLink ICP Monitor is intended for use in the ICU or OR environment for monitoring intracranial pressure (ICP) via a solid state sensor placed directly in parenchymal tissue or integrated into an external ventricular drainage catheter placed in the ventricle. In addition to monitoring ICP and activating alarms when the intracranial pressure is outside user-set limits, the device performs these functions: - Displays mean pressure values - Displays the pressure waveform - Displays the historic mean pressure as a trend - Displays trend statistics (Area Under the Curve (AUC), time above threshold, boxplot, histogram) - Stores 14-days' worth of mean ICP values - Stores 24 hours of pressure waveform - Can capture and store screen-shots - Can download various data to a USB device for printing or analysis The CereLink ICP Monitor can be transported with the patient within the hospital to continuously record data. The monitor includes a 7" color touch screen that is compatible with the use of gloves. The monitor is sold with an external power supply, and comes equipped with an internal rechargeable battery. The monitor has one output channel to transfer physiological data to a compatible Patient Monitor, as well as one input channel to receive ICP readings from the implanted ICP sensor. The implanted sensor is connected to the CereLink ICP Monitor by way of the CereLink ICP Extension Cable (code 82-6845). The CereLink ICP Monitor and CereLink ICP Extension Cable are intended to be used in conjunction with Codman's other neuromonitoring devices: the CereLink ICP Sensor Kits (codes 82-6850, 82-6851, 82-6852, and 82-6854 cleared via K173192) and the patient monitor interface cables (codes 82-6880, 82-6881, and 82-6882 cleared via K152670). The CereLink ICP Sensor converts the patients intracranial pressure 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 CereLink ICP Sensor Kits or the patient monitor interface cables as a result of the monitor modifications described in this submission.

The Codman Certas Plus Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

This submission includes two additional configurations of the Codman Certas Plus Programmable Valve: Certas Plus Inline Small and Certas Plus Right Angle. The Codman Certas Plus Programmable Valves are sterile, single use, implantable devices designed for shunting cerebrospinal fluid (CSF) for the treatment of hydrocephalus. The Codman Certas Plus Programmable Valve is a pressure-regulating valve utilizing the ruby ball-in-cone principle with a pressure inducing spring design. Intraventricular pressure is maintained by the ball and cone valve seat design. As the differential pressure across the shunt increases, the ball further displaces from the cone, through which CSF flows, thereby increasing flow and re-establishing the selected pressure. The ball is manufactured of synthetic ruby, as is the matching cone. Together these components provide a precise fit for regulating the flow of CSF through the valve. The valve is available with 8 different performance settings for constant intraventricular pressure and drainage of CSF. Seven (7) of the settings provide a change in operating pressure, with a range of 25 to 215 mmH2O. The eighth (8) setting provides a minimum opening pressure of '400' mmH20, thus allowing a physician to turn the valve "virtually off" without the need to surgically remove the valve to limit flow. The pressure of the valve is set preoperatively and can be noninvasively changed postimplantation by using the Codman Certas Tool Kit.

The Codman Certas Plus Electronic Tool Kit allows the non-invasive reading or adjustment of the Codman Certas and Certas Plus Programmable Valves.

The Certas Plus Electronic Tool Kit is used to non-invasively read or adjust the setting of a Certas or Certas Plus Programmable Valve before and after implantation in the treatment of hydrocephalus. The Certas Plus Electronic Tool Kit consists of the following tools: Locator/Indicator Tool, Adjustment Tool and X-Ray Overlay Tool. The Locator/Indicator Tool facilitates correct placement of the Adjustment Tool over a pre-implanted valve in the packaging or a post-implanted valve, and measures the valve's magnetic field to display the valve setting. The Adjustment Tool adjusts the valve to one of the 8 valve settings. The magnets in the Adjustment Tool couple with the magnets in the rotating construct of the valve, causing the rotating construct to lift and follow the Adjustment Tool as it is rotated to one of 8 valve settings.

The CUSA® Excel+ Ultrasonic Surgical Aspirator System is indicated for fragmentation, emulsification and aspiration of soft and hard (e.g.: bone) tissue in the following surgical specialties: Neurosurgery, Orthopedic Surgery, Plastic and Reconstructive Surgery and the following specific uses: Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant turnors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy Urological Surgery - including removal of renal parenchyma during nephrectomy or partial nephrectomy General Surgery - including removal of benign or malignant turnors or other unwanted soft or hard tissue in open or minimally invasive general surgical procedures Laparoscopic Surgery – including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy Gynecological Surgery - including removal of dysplastic genital epithelial tissue including vulvar and vaginal intraepithelial neoplasia, removal of condyloma, debulking of metastatic uterine, ovarian, fallopian tube or primary peritoneal carcinoma, and open or laparoscopic excision of tissue and adhesions associated with endometriosis.

The CUSA® Excel+ Ultrasonic Surgical Aspirator System (CUSA) is an ultrasonically vibrating surgical device which, in combination with irrigation, fragments, emulsifies and removes unwanted tissue. It allows the selective dissection of target tissue while preserving vessels, ducts and other delicate structures. The CUSA Excel+ System consists of a console which provides control and power functions, two surgical hand pieces which provide ultrasonic mechanical energy (23kHz and 36kHz), titanium hand piece tips (variety of models), flexible irrigation flue, and a suction/irrigation system (manifold tubing and cooling water canister). The CUSA Excel+ system accommodates most commercially available suction canisters. A two-pedal footswitch is provided with the console.

Integra® (Jarit®, Ruggles™-Redmond™, Miltex®, MeisterHand®) Kerrison Rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column.

Integra® Kerrison Rongeurs are reusable stainless steel instruments that are sterilizable and packaged non-sterile. Devices are available with the following features: with or without proprietary surface treatments; 1-6 mm bite sizes; 9 - 15.5 mm jaw openings; 40° and 90° up/down cutting angles: regular and thin/low profile footplates: standard and eiector tips: 4.75 -15" shaft lengths; and various handle and shaft styles, including Detach®. Integra® Kerrison Rongeurs are distributed under the following brand names: Jarit®, Ruggles™ -Redmond™, Miltex®, and MeisterHand®.

The Integra Licox PtO₂ monitor measures oxygen partial pressure (PtO2) and temperature in brain tissue and these parameters are used together as an aid in the determination of the perfusion status of cerebral tissue local to sensor placement. Monitor values are relative within an individual, and should not be used as the sole basis for determining a diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice in cases where hypoxia or ischemia are a concern.

The Integra® Licox® PtO2 monitor instrument is a diagnostic tool for continuously monitoring oxygen partial pressure (PtO2) in - brain tissue. Minimally invasive probes are implanted directly into the brain tissue and are connected to the Licox monitor. The Integra Licox PtO2 Monitor displays both PtO2 and temperature in numeric format. The monitor will store PtO2 trend data from the most recent 5 days. The user can elect to extract the trend data stored on the monitor to an external memory device or stream the data to a compatible PC via the USB output. The device also provides analog output for display on compatible bedside monitors.

Integra™ (Jarit®, Ruggles™, R&B Redmond™(Redmond™), Miltex®, MeisterHand®) Kerrison Rongeurs are manually operated instruments indicated for cutting bone during surgery involving the skull or spinal column.

Integra™ Kerrison Rongeurs are reusable stainless steel instruments that are sterilizable and packaged non-sterile. Devices are available with the following features: with or without proprietary surface treatments; 1-6 mm bite sizes; 9 - 15.5 mm jaw openings; 40° and 90° up/down cutting angles; regular and thin/low profile footplates; standard and ejector tips; 4.75 - 15" shaft lengths; and various handle and shaft styles, including Detach®. Integra™ Kerrison Rongeurs are distributed under the following brand names: Jaril®, Ruggles™, R&B Redmond™(Redmond™), Miltex®, MeisterHamd®.

Both the OSV II Lumbar Valve System and the OSV II Low Flow Lumbar Valve System are indicated as implantable systems used in the treatment of patients with communicating hydrocephalus to shunt CSF from the lumbar subarachnoid region to the peritoneal cavity.

The OSV II® Lumbar Valve System (OSV II Valve) and the OSV II® Low Flow Lumbar Valve System (OSV II Low Flow Valve) are implantable devices for controlled cerebrospinal fluid drainage (CSF) from the lumbar subarachnoid region to the peritoneal cavity. Unlike conventional valves, they are variable resistance valves which maintain a drainage rate constant within the physiological range (for the specified populations and disorders) of intracranial pressure. They maintain a drainage rate around 20ml/hr for OSV II Valves and around 10ml/hr for OSV II Low Flow Valves. The OSV II Lumbar Valve System and OSV II Low Flow Lumbar Valve System are provided with accessories including a 14G tuohy needle, a F5 lumbar catheter, a guidewire, a luer lock connector and a F8-F5 stepdown connector, which are required for using the valves in a lumbar approach. The designs of the accessories are identical to the accessories currently provided with the Integra H-V Lumbar Valve System.

INTEGRA™ Meshed Bilayer Wound Matrix is indicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds. The device may be used in conjunction with negative pressure wound therapy. The device is intended for one-time use.

INTEGRA™ Meshed Bilayer Wound Matrix is an advanced wound care device comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminonlycan with a polysiloxane (silicone) layer. The meshed bilayer matrix allows drainage of wound exudate and provides a flexible adherent covering for the wound surface. The collagen- glycosaminoglycan biodegradable matrix provides a scaffold for cellular invasion and capillary growth.