PMA supplement
P820012 S006: COSMAN ICP TELE-SENSOR(R)
FDA PMA supplement · Normal 180 Day Track · Integra Lifesciences Corp.
Key facts
| Original PMA | P820012 |
|---|---|
| Supplement number | S006 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | COSMAN ICP TELE-SENSOR(R) |
| Generic name | Monitor, intracranial pressure, implanted |
| Applicant | Integra Lifesciences Corp. |
| Product code | LII |
| Received date | Aug 3, 1998 |
| Decision date | Jul 29, 1999 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: