PMA
P120011: Puregraft Serene Breast Implant
FDA PMA · Prosthesis, breast, inflatable, internal, saline · Bimini Health Tech
Key facts
| PMA number | P120011 |
|---|---|
| Trade name | Puregraft Serene Breast Implant |
| Generic name | Prosthesis, breast, inflatable, internal, saline |
| Applicant | Bimini Health Tech |
| Owner/operator | Bimini Health Tech |
| Product code | FWM |
| Approval date | Nov 14, 2014 |
| Docket number | 14M-2042 |
| Notice date | Nov 25, 2014 |
| Establishment registration | 3022978896 |
| FEI number | 3022978896 |
At a glance
- 10–99 Supplements
- Feb 11, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: