Identity
- Trade Name
- COSMAN ICP TELE-SENSOR(R) FDA PMA
- Generic Name
- Monitor, intracranial pressure, implanted FDA PMA
Identifiers
- PMA Number
- P820012 FDA PMA
- FDA Product Code
- LII FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Neurology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
- PMA Supplement
- S005 FDA PMA
The Cosman ICP Tele-Sensor is an implanted intracranial pressure monitor designed to measure and transmit intracranial pressure (ICP) data in real-time. Classified as a Monitor, Intracranial Pressure, Implanted, it is intended for use in neurosurgical patients requiring continuous ICP monitoring to assess brain injury, hydrocephalus, or other conditions affecting cerebrospinal fluid dynamics.
This device is supplied sterile and intended for single-use, though it may be implanted permanently for prolonged monitoring. It is regulated under FDA Premarket Approval (PMA) with PMA number P820012 and falls under device class III. The sensor is designed for use in clinical settings where MRI safety considerations must be evaluated, and it is supplied as part of a kit including necessary implantation tools and sterile packaging.
Frequently asked questions
What is the Cosman ICP Tele-Sensor primarily used for in clinical settings?
The Cosman ICP Tele-Sensor is designed for continuous intracranial pressure (ICP) monitoring in neurosurgical patients. It helps assess conditions like brain injury, hydrocephalus, or other cerebrospinal fluid dynamics disorders by providing real-time ICP data, enabling clinicians to make informed decisions about patient care.
Is the Cosman ICP Tele-Sensor intended for single-use or can it be reused after implantation?
While the Cosman ICP Tele-Sensor is supplied sterile and labeled for single-use, it is explicitly designed for permanent implantation when prolonged monitoring is required. This means it can remain in place for extended periods rather than being removed after a single procedure.
What components are included in the Cosman ICP Tele-Sensor kit, and how is it packaged?
The Cosman ICP Tele-Sensor is supplied as part of a kit that includes the sensor itself along with necessary implantation tools. The entire kit is packaged sterile to ensure readiness for immediate use in clinical settings.
Does the Cosman ICP Tele-Sensor have any special considerations for use in MRI environments?
Yes, the Cosman ICP Tele-Sensor requires evaluation for MRI safety before use in magnetic resonance imaging environments. Clinicians must verify compatibility with their specific MRI protocols to ensure patient safety during scans.
How was the Cosman ICP Tele-Sensor regulated by the FDA, and what does that mean for its use?
The Cosman ICP Tele-Sensor was approved through the FDA’s Premarket Approval (PMA) process, indicated by PMA number P820012. This means it underwent rigorous review to ensure safety and effectiveness before being authorized for use in clinical settings, adhering to strict regulatory standards for Class III devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P820012 | Class III | Active |
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Manufacturer
- Manufacturer
- Integra Lifesciences Corp.
Sources (1)
- FDA PMA P820012 24 fields · synced Oct 6, 2026