PMA supplement
P230005 S005: Motiva SmoothSilk® Round and Round Ergonomix® Silicone Gel-Filled Breast Implants
FDA PMA supplement · 135 Review Track For 30-Day Notice · Motiva USA, LLC
Key facts
| Original PMA | P230005 |
|---|---|
| Supplement number | S005 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Motiva SmoothSilk® Round and Round Ergonomix® Silicone Gel-Filled Breast Implants |
| Generic name | Prosthesis, breast, noninflatable, internal, silicone gel-filled |
| Applicant | Motiva USA, LLC |
| Product code | FTR |
| Received date | Apr 2, 2026 |
| Decision date | Sep 25, 2026 |
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: