PMA
P050044: VITAGEL RT3 SUTGICAL HEMOSTAT
FDA PMA · Absorbable collagen hemostatic agent with thrombin · Stryker Corp.
Key facts
| PMA number | P050044 |
|---|---|
| Trade name | VITAGEL RT3 SUTGICAL HEMOSTAT |
| Generic name | Absorbable collagen hemostatic agent with thrombin |
| Applicant | Stryker Corp. |
| Owner/operator | STRYKER CORP. |
| Product code | PMX |
| Approval date | Jun 16, 2006 |
| Docket number | 06M-0293 |
| Notice date | Jul 26, 2006 |
| Establishment registration | 1811755 |
| FEI number | 1811755 |
At a glance
- 10–99 Supplements
- Mar 2, 2017 Latest supplement decision
- Yes Withdrawn
- Yes 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: