PMA P820012
- Device
- COSMAN ICP TELE-SENSOR(R)
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P820012
- Supplement
- S006
- Product code
- LII
- Decision date
- 1999-07-29
- Generic name
- Monitor, intracranial pressure, implanted
- Approval order statement
- Approval for the addition of a polypropylene connector to the ventricular catheter side of the Tele-Sensor(R).
Current openFDA PMA Record
- Device
- COSMAN ICP TELE-SENSOR(R)
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P820012
- Supplement
- S006
- Product code
- LII
- Generic name
- Monitor, intracranial pressure, implanted
- Decision date
- 1999-07-29
- Decision code
- APPR
- Date received
- 1998-08-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the addition of a polypropylene connector to the ventricular catheter side of the Tele-Sensor(R).