PMA
P830079: INSTAT(TM) COLLAGEN ABSORBABLE HEMOSTAT
FDA PMA · Agent, absorbable hemostatic, collagen based · ETHICON, Inc.
Key facts
| PMA number | P830079 |
|---|---|
| Trade name | INSTAT(TM) COLLAGEN ABSORBABLE HEMOSTAT |
| Generic name | Agent, absorbable hemostatic, collagen based |
| Applicant | ETHICON, Inc. |
| Owner/operator | ETHICON INC. |
| Product code | LMF |
| Approval date | Oct 10, 1985 |
| Docket number | 85M-0507 |
| Notice date | Nov 15, 1985 |
| Establishment registration | 2210968 |
| FEI number | 2210968 |
At a glance
- 10–99 Supplements
- Nov 28, 2007 Latest supplement decision
- Yes Withdrawn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: