PMA supplement
P900033 S098: Integra® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template and Integra® Omnigraft Dermal Regene
FDA PMA supplement · 135 Review Track For 30-Day Notice · Integra Lifesciences Corp.
Key facts
| Original PMA | P900033 |
|---|---|
| Supplement number | S098 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Integra® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template and Integra® Omnigraft Dermal Regene |
| Generic name | Dressing, wound and burn, interactive |
| Applicant | Integra Lifesciences Corp. |
| Product code | MGR |
| Received date | Dec 15, 2021 |
| Decision date | May 17, 2022 |
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: