PMA supplement
P030053 S036: MEMORYGEl BREAST IMPLANTS
FDA PMA supplement · 135 Review Track For 30-Day Notice · Mentor Corp.
Key facts
| Original PMA | P030053 |
|---|---|
| Supplement number | S036 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | MEMORYGEl BREAST IMPLANTS |
| Generic name | Prosthesis, breast, noninflatable, internal, silicone gel-filled |
| Applicant | Mentor Corp. |
| Product code | FTR |
| Received date | Nov 22, 2016 |
| Decision date | May 8, 2017 |
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: