PMA
P900030: CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT
FDA PMA · AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE · Allergan, Inc.
Key facts
| PMA number | P900030 |
|---|---|
| Trade name | CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT |
| Generic name | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE |
| Applicant | Allergan, Inc. |
| Owner/operator | AbbVie, Inc. |
| Product code | LNM |
| Approval date | Sep 30, 1993 |
| Establishment registration | 2011068 |
| FEI number | 2011068 |
At a glance
- 10–99 Supplements
- Oct 2, 2009 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- None 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: