PMA supplement
P070004 S033: Sientra OPUS Silicone Gel Breast Implants
FDA PMA supplement · Normal 180 Day Track · Tiger Aesthetics Medical, LLC
Key facts
| Original PMA | P070004 |
|---|---|
| Supplement number | S033 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Sientra OPUS Silicone Gel Breast Implants |
| Generic name | Prosthesis, breast, noninflatable, internal, silicone gel-filled |
| Applicant | Tiger Aesthetics Medical, LLC |
| Product code | FTR |
| Received date | Aug 6, 2021 |
| Decision date | Oct 27, 2021 |
At a glance
- No Expedited review granted
- Yes 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: