PMA
P900033: INTEGRA DERMAL REGENERATION TEMPLATE
FDA PMA · Dressing, wound and burn, interactive · Integra Lifesciences Corp.
Key facts
| PMA number | P900033 |
|---|---|
| Trade name | INTEGRA DERMAL REGENERATION TEMPLATE |
| Generic name | Dressing, wound and burn, interactive |
| Applicant | Integra Lifesciences Corp. |
| Owner/operator | Integra LifeSciences Corporation |
| Product code | MGR |
| Approval date | Mar 1, 1996 |
| Docket number | 96M-0203 |
| Notice date | Jul 18, 1996 |
| Establishment registration | 1121308 |
| FEI number | 1121308 |
At a glance
- 100–999 Supplements
- Sep 18, 2026 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: