PMA
P870069: BIOBRANE(R) II
FDA PMA · Dressing, wound, drug · Udl Laboratories, Inc.
Key facts
| PMA number | P870069 |
|---|---|
| Trade name | BIOBRANE(R) II |
| Generic name | Dressing, wound, drug |
| Applicant | Udl Laboratories, Inc. |
| Product code | FRO |
| Approval date | Oct 20, 1989 |
| Docket number | 89M-0491 |
| Notice date | Dec 6, 1989 |
At a glance
- 1–9 Supplements
- Feb 22, 1991 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- Yes Withdrawn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: