COSMAN ICP TELE-SENSOR(R)
FDA premarket approval P820012/S006 · decided 1999-07-29
Approval details
- PMA number
- P820012
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COSMAN ICP TELE-SENSOR(R)
- Generic name
- Monitor, intracranial pressure, implanted
- Applicant
- Integra Lifesciences Corp.
- Date received
- 1998-08-03
- Decision date
- 1999-07-29
- Days to decision
- 360 days
- Decision code
- APPR
- Product code
- LII
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Burlington, MA
- Statement
- Approval for the addition of a polypropylene connector to the ventricular catheter side of the Tele-Sensor(R).
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