PMA supplement
P900033 S042: INTEGRA(R) DERMAL REGENERATION TEMPLATE,INTEGRA(R) MESHED DERMAL REGENERATION TEMPLATE,OMNIGRAFT (TM) DERMAL REGENERATIO
FDA PMA supplement · Panel Track · Integra Lifesciences Corp.
Key facts
| Original PMA | P900033 |
|---|---|
| Supplement number | S042 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | INTEGRA(R) DERMAL REGENERATION TEMPLATE,INTEGRA(R) MESHED DERMAL REGENERATION TEMPLATE,OMNIGRAFT (TM) DERMAL REGENERATIO |
| Generic name | Device, dermal replacement |
| Applicant | Integra Lifesciences Corp. |
| Product code | MDD |
| Received date | Jan 29, 2015 |
| Decision date | Jan 7, 2016 |
| Docket number | 16M-0121 |
| Notice date | Jan 11, 2016 |
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: