PMA supplement
P800022 S013: ZYDERM COLLAGEN IMPLANT (ZYDERM CI)
FDA PMA supplement · Allergan
Key facts
| Original PMA | P800022 |
|---|---|
| Supplement number | S013 |
| Trade name | ZYDERM COLLAGEN IMPLANT (ZYDERM CI) |
| Generic name | IMPLANT, COLLAGEN FOR NON-AESTHETIC USE |
| Applicant | Allergan |
| Product code | LMI |
| Received date | Aug 26, 1985 |
| Decision date | Nov 22, 1985 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: