PMA supplement
P900033 S053: INTEGRA(R) DERMAL REGENERATION TEMPLATE, INTEGRA(R) MESHED DERMAL REGENERATION TEMPLATE
FDA PMA supplement · Normal 180 Day Track · Integra Lifesciences Corp.
Key facts
| Original PMA | P900033 |
|---|---|
| Supplement number | S053 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | INTEGRA(R) DERMAL REGENERATION TEMPLATE, INTEGRA(R) MESHED DERMAL REGENERATION TEMPLATE |
| Generic name | Device, dermal replacement |
| Applicant | Integra Lifesciences Corp. |
| Product code | MDD |
| Received date | Nov 3, 2015 |
| Decision date | May 9, 2016 |
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: