|
Device | COSMAN ICP TELE-SENSOR(R) |
Generic Name | Monitor, intracranial pressure, implanted |
Applicant | Integra LifeSciences Corp. 22 TERRY AVENUE BURLINGTON, MA 01803 |
PMA Number | P820012 |
Supplement Number | S006 |
Date Received | 08/03/1998 |
Decision Date | 07/29/1999 |
Withdrawal Date
|
09/20/2011 |
Product Code |
LII |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of a polypropylene connector to the ventricular catheter side of the Tele-Sensor(R). |