PMA
P060028: MENTOR MEMORYSHAPE BREAST IMPLANTS
FDA PMA · Prosthesis, breast, noninflatable, internal, silicone gel-filled · Mentor Worldwide, LLC
Key facts
| PMA number | P060028 |
|---|---|
| Trade name | MENTOR MEMORYSHAPE BREAST IMPLANTS |
| Generic name | Prosthesis, breast, noninflatable, internal, silicone gel-filled |
| Applicant | Mentor Worldwide, LLC |
| Owner/operator | MENTOR Texas, LP |
| Product code | FTR |
| Approval date | Jun 14, 2013 |
| Docket number | 13M-0738 |
| Notice date | Jun 19, 2013 |
| Establishment registration | 1645337 |
| FEI number | 1000118360 |
At a glance
- 10–99 Supplements
- Jul 21, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 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: