PMA
P800022: ZYDERM COLLAGEN IMPLANT (ZYDERM CI)
FDA PMA · Implant, dermal, for aesthetic use · Allergan
Key facts
| PMA number | P800022 |
|---|---|
| Trade name | ZYDERM COLLAGEN IMPLANT (ZYDERM CI) |
| Generic name | Implant, dermal, for aesthetic use |
| Applicant | Allergan |
| Owner/operator | AbbVie, Inc. |
| Product code | LMH |
| Approval date | Jul 22, 1981 |
| Docket number | 81M-0237 |
| Notice date | Sep 18, 1981 |
| Establishment registration | 2011068 |
| FEI number | 2011068 |
At a glance
- 10–99 Supplements
- Dec 19, 2006 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- Yes Withdrawn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: