PMA supplement
P900033 S008: INTEGRA DERMAL REGENERATION TEMPLATE
FDA PMA supplement · Panel Track · Integra Lifesciences Corp.
Key facts
| Original PMA | P900033 |
|---|---|
| Supplement number | S008 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | INTEGRA DERMAL REGENERATION TEMPLATE |
| Generic name | Device, dermal replacement |
| Applicant | Integra Lifesciences Corp. |
| Product code | MDD |
| Received date | Oct 26, 2001 |
| Decision date | Apr 19, 2002 |
| Docket number | 02M-0216 |
| Notice date | May 13, 2002 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: