PMA supplement
P120011 S028: Puregraft Serene Breast Implant, IDEAL IMPLANT Structured Breast Implant
FDA PMA supplement · Normal 180 Day Track No User Fee · Bimini Health Tech
Key facts
| Original PMA | P120011 |
|---|---|
| Supplement number | S028 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - PAS |
| Trade name | Puregraft Serene Breast Implant, IDEAL IMPLANT Structured Breast Implant |
| Generic name | Prosthesis, breast, inflatable, internal, saline |
| Applicant | Bimini Health Tech |
| Product code | FWM |
| Received date | Aug 16, 2024 |
| Decision date | Feb 11, 2025 |
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: