PMA supplement
P120011 S012: IDEAL IMPLANT Structured Breast Implant
FDA PMA supplement · Real-Time Process · Bimini Health Tech
Key facts
| Original PMA | P120011 |
|---|---|
| Supplement number | S012 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | IDEAL IMPLANT Structured Breast Implant |
| Generic name | Prosthesis, breast, inflatable, internal, saline |
| Applicant | Bimini Health Tech |
| Product code | FWM |
| Received date | Jun 11, 2018 |
| Decision date | Aug 6, 2018 |
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: