PMA supplement
P060028 S001: MEMORYSHAPE BREAST IMPLANTS, CONTOUR PROFILE GEL IMPLANTS
FDA PMA supplement · Normal 180 Day Track · Mentor Worldwide, LLC
Key facts
| Original PMA | P060028 |
|---|---|
| Supplement number | S001 |
| Supplement type | Normal 180 Day Track |
| Trade name | MEMORYSHAPE BREAST IMPLANTS, CONTOUR PROFILE GEL IMPLANTS |
| Generic name | Prosthesis, breast, noninflatable, internal, silicone gel-filled |
| Applicant | Mentor Worldwide, LLC |
| Product code | FTR |
| Received date | Mar 26, 2014 |
| Decision date | Sep 9, 2014 |
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: