PMA
P850053: FIBREL
FDA PMA · Implant, dermal, for aesthetic use · Mentor Corp.
Key facts
| PMA number | P850053 |
|---|---|
| Trade name | FIBREL |
| Generic name | Implant, dermal, for aesthetic use |
| Applicant | Mentor Corp. |
| Owner/operator | MENTOR Texas, LP |
| Product code | LMH |
| Approval date | Feb 26, 1988 |
| Docket number | 88M-0094 |
| Notice date | May 3, 1988 |
| Establishment registration | 1645337 |
| FEI number | 1000118360 |
At a glance
- 1–9 Supplements
- Aug 14, 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- Yes Withdrawn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: