PMA
P840062: COLLACOTE(TM)
FDA PMA · MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID · Integra Lifesciences Corp.
Key facts
| PMA number | P840062 |
|---|---|
| Trade name | COLLACOTE(TM) |
| Generic name | MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID |
| Applicant | Integra Lifesciences Corp. |
| Owner/operator | Integra LifeSciences Corporation |
| Product code | LPG |
| Approval date | Nov 8, 1985 |
| Docket number | 85M-0556 |
| Notice date | Jan 2, 1986 |
| Establishment registration | 1121308 |
| FEI number | 1121308 |
At a glance
- 10–99 Supplements
- Sep 18, 2026 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 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: