PMA
P960057: ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL
FDA PMA · Inhibitor, peridural fibrosis (adhesion barrier) · Wrightmedicaltechnologyinc
Key facts
| PMA number | P960057 |
|---|---|
| Trade name | ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL |
| Generic name | Inhibitor, peridural fibrosis (adhesion barrier) |
| Applicant | Wrightmedicaltechnologyinc |
| Product code | MLQ |
| Approval date | May 27, 1998 |
| Docket number | 98M-0404 |
| Notice date | Jun 23, 1998 |
At a glance
- 1–9 Supplements
- Sep 27, 2000 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- Yes Withdrawn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: