PMA
P850010: HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
FDA PMA · Agent, absorbable hemostatic, collagen based · Integra LifeSciences Corporation
Key facts
| PMA number | P850010 |
|---|---|
| Trade name | HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE |
| Generic name | Agent, absorbable hemostatic, collagen based |
| Applicant | Integra LifeSciences Corporation |
| Owner/operator | Integra LifeSciences Corporation |
| Product code | LMF |
| Approval date | Nov 8, 1985 |
| Docket number | 85M-0557 |
| Notice date | Jan 2, 1986 |
| 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- No Withdrawn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
- 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: