Search Results

The PMT® TruScan® Surface Electrodes are indicated for cutaneous use in the general recording and monitoring of the Electroencephalograph (EEG) and Evoked Potential (EP). The PMT® TruScan® Surface Electrodes are CT compatible and MR Conditional under the following conditions: - Static magnetic field strength of 1.5-T only - Maximum spatial gradient magnetic field of 5,000 Gauss/cm (50T/m) or less - The connector hub must be placed near the center MR system's bore, and must be at least 20-cm from the wall of the MR system's bore at all times. - The extension cable must be disconnected from the PMT TruScan Surface Electrode before scanning and MUST remain disconnected throughout the entire MR scan. - Normal Operating Mode of operation for the MR system with a maximum whole body averaged specific absorption rate (SAR) of 2.0-W/kg for 15 minutes of scanning (i.e., per pulse sequence)

The PMT® TruScan® Surface Electrodes are non-invasive, cutaneous devices used in the acquisition of signals for the purpose of monitoring and recording Electroencephalograph (EEG) and Evoked Potentials (EP). The reusable TruScan® Surface Electrodes have a disc with a diameter of 10 mm coated with silver / silver chloride (Ag/AgCl). Each disc is permanently adhered to an insulated lead wire. An extension cable is required to connect the Truscan® Surface Electrodes to the recording equipment. The extension cable is electrically insulated and terminated by a molded touch proof connector that is compliant to the safety requirements outlined in IEC 60601-1 subclause 56.3(c). During a MRI examination, the extension cable must be disconnected from the TruScan® Surface Electrodes. Numbered and color coated lead wires are provided to facilitate identification. The electrodes are provided non-sterile and can be reused.

The PMT Halo System with Open Back Carbon Graphite and Titanium Skull Pins and the PMT Halo System with Closed Back Carbon Graphite and Titanium Skull Pins provides cervical immobilization necessary for healing and rehabilitation of cervical spinal cord injuries. The PMT Halo system is MR Conditional and may be used safely in an MRI under the following conditions: - Static magnetic field of 1.5T and 3T only . - Maximum spatial gradient magnetic field of 720 Gauss/cm or less . - Normal operating mode with a maximum MR system reported, whole body averaged specific absorption rate (SAR) ● of 3.0 W/kg for 15 minutes of scanning (per pulse sequence).

The PMT Halo System is designed for positioning and stabilization of the cervical spine area. It provides optimum external immobilization and traction for the cervical region while allowing the patient to leave the hospital and resume their normal activities. To enhance the magnetic resonance imaging compatibility, the PMT Halo system utilizes non-magnetic titanium skull pins and hardware, brass positioning pins, and advanced non-metallic support materials such as carbon graphite upright bars and composite head fixation subassemblies.

Catalog Numbers 2110-XXX: The Subdural Cortical Electrodes (Dual Side Macro Electrodes, Dual Side Micro Electrodes, Dual Side Macro-Micro Electrodes, Dual Sided Hemispherical Macro Electrodes, Dual Sided Hemispherical Micro Electrodes, Dual Side Hemispherical Macro-Micro Electrodes, Macro Grids, Macro Strip, Macro-Micro Grids, Macro-Micro Strips, Micro Grids, and Micro Strips.) are intended for temporary (<30 day) use with recording, monitoring, and stimulation equipment for the recording, monitoring and stimulation of electrical signals on the surface of the brain. This device is restricted to the sale by or on the order of a physician.

PMT Subdural Cortical Electrodes (Dual Side Macro Electrodes, Dual Side Micro Electrodes, Dual Side Macro-Micro Electrodes, Dual Sided Hemispherical Macro Electrodes, Dual Sided Hemispherical Micro Electrodes, Dual Side Hemispherical Macro-Micro Electrodes, Macro Strip, Macro-Micro Grids, Macro-Micro Strips, Micro Grids, and Micro Strips.) The Subdural Cortical Electrode is used intraoperatively for monitoring recordable electrical brain activity. This invasive intracranial, subdural electrode recording is performed directly on the surgically exposed brain. This method is necessary when the seizure focus is too small and or too deep within the brain to produce a recordable EEG seizure. The Subdural Cortical Electrode strip and grid electrode are used in cases where it is necessary to establish a high degree of confidence in the electrical localization (foci), seizure frequency, severity type and other electro-clinical characteristics. Macro Electrodes use 2mm, 3mm or 4.5mm diameter platinum circular recording discs. Micro Electrodes are single wires with the distal tip exposed and flush with the surface of the silicone. They are made of the same material used in the assembly of the Electrode. The Micro electrode allow for more precise definition of the Epileptic activity. They can be used solo or in combination with Macro recording discs. The PMT device consists of one or more electrically contacts. The model number 2110 indicates a platinum alloy wire and platinum alloy electrode contacts. The electrodes' contacts are molded into a silicone rubber matrix in a fixed pattern. Insulated wires extend from each electrode through a flexible silicone tube to connector for EEG monitoring. The electrode material for the 2110-XXX is 90:10 platinum iridium

The Endomark™ Sterile India Ink is indicated for endoscopically marking lesions in the GI tract when the endoscopist anticipates the lesion will require surgical removal within thirty days.

The Endomark™ Sterile India Ink is a sterile, non-pyrogenic ink designed to be used as an endoscopic marker for marking polyps and lesions in the gastrointestinal tract. It is supplied in single-use 10 mL vials.

The PMT SPHENOIDAL Electrode is indicated for Intraoperative recording of electrical signals for Epilepsy monitoring at the surface and subsurface levels of the brain. It is not intended for long term monitoring.

The PMT Sphenoidal electrode consists of an insulated Platinum/lridum or Stainless Steel wire with an exposed distal portion used to record EEG activity. The proximal end of the wire terminates in a connector. The connector attaches to an Interconnection cable external to the patient and connected to the EEG equipment. The PMT Sphenoidal electrode is introduced to the recording site via an introducer. Once in place, the introducer is removed leaving the electrode available for recording EEG patterns from the inferior mesial temporal lobe. The PMT Sphenoidal Electrode is provided sterile for single use and for Intraoperative use only.

Management of hypertrophic and keloid scars.

PMT®'s Model 5100 New Beginnings™ GelShapes™ & Amend™ consist of a solid piece of low durometer medical grade silicone with a thin, high durometer silicone backing. Certain GelShapes™ & Amend™ also have reinforcement material for added strength. The silicone gel sheeting is used on hypertrophic or keloid scars in order to soften or lighten the color of these scars. The model 5100 New BeginningsTM GelShapes™ & Amend™ are used only externally and on intact skin.

Not Found

The PMT Depth Electrode Anchor Bolt is an accessory used in cases where it's necessary to minimize concerns about potential cerebrospinal fluid (CSF) leakage and infection of the subdural space while stabilizing the electrode during intraoperative electroclincal characterization. The PMT Depth Electrode Anchor Bolt is attached onto the skulls with the insertion of the Anchor Bolt Tapered Screw Threads into a pre-drilled burr hole, through a skin incision. Once installed on to the skull a PMT Depthalon® Depth Electrode (510(k) number K802151 and K802152) can be inserted into the Anchor Bolt Screw Cap Port Hole through the Silicone Gasket and into the cranium. The PMT Depth Electrode Anchor Bolt is made of Titanium alloy (Ti 6Al 4V) with a silicone gasket. The gasket is designed to accept the PMT Depthalon® Depth Electrode. The port hole of the PMT Depth Electrode Anchor Bolt is designed to accommodate depth electrodes with a diameter of 0.050 ± .005 inches. Additional designs will be made available to accommodate different manufactures and models of Depth Electrodes with various diameters. Once the Depth Electrode is at the intended foci, the Port Hole Screw Cap can be tightened to fixture the PMT Depthalon® Depth Electrode . The Device is designed to withstand a longitudinal ( push/ pull)100 gram force. The PMT Depth Electrode Anchor Bolt is available in 25mm, 30mm, 35mm and 40mm lengths to accommodate neurophysiologist preference. The PMT Depth Electrode Anchor Bolt is provided in a primary and secondary pouch. The pouch is a Tyvek and cellophane configuration. The Tyvek pouch with the chevron design feature provides a 1- 3 lb. pull apart strength. The PMT Depth Electrode Anchor Bolt is provided sterile or non-sterile. The type of sterilization used is 100% Ethylene Oxide. The sterilization method employed is the overkill method and validated to the terminal process endpoint probability of a non-sterile unit of 10°. The PMT Depth Electrode Anchor Bolt is provided pyrogen free. The method of determination is the Limulus Amebocyte Lysate Test. The Bacterial Endotoxin test is conducted as described in the USP Endotoxin Reference Standard. The pyrogen limit for the PMT Depth Electrode Anchor Bolt is 2.4 Eu/device. The PMT Depthalon® Electrode Anchor Bolt is tested for biocompatibility. The silicone gasket material has been tested per the General Program Memo # G95-1. the device is classified as an implant device, contacting tissue/ bone with an "A" class duration of contact (< 24 hours). The silicone materials used passed the tests for Cytotoxicity, Sensitization, Irritation and Acute Systemic toxicity. The Titanium alloy has passed the Intracutaneous, Acute Systemic Toxicity and Sensitization test (Implant).

Not Found

The Cortac Cortical Electrode is used intraoperatively for monitoring recordable electrical brain activity or Electroencephalography (EEG) when less invasive methods do not provide the electrophysiology data necessary. This invasive intracranial, subdural electrode recording is performed directly on the surgically exposed brain. This method is necessary when the seizure focus is to small and or to deep within the brain to produce a recordable EEG seizure. The Cortac Cortical Subdural strip and grid electrode are used in cases where it's necessary to establish a high degree of confidence in the electrical localization (Foci), seizure frequency, severity type and other electroclincal characteristics.