PMA
P230005: Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone Gel-Filled Breas
FDA PMA · Prosthesis, breast, noninflatable, internal, silicone gel-filled · Motiva USA, LLC
Key facts
| PMA number | P230005 |
|---|---|
| Trade name | Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone Gel-Filled Breas |
| Generic name | Prosthesis, breast, noninflatable, internal, silicone gel-filled |
| Applicant | Motiva USA, LLC |
| Owner/operator | Establishment Labs- Motiva USA LLC |
| Product code | FTR |
| Approval date | Sep 26, 2024 |
| Docket number | 24M-4559 |
| Establishment registration | 3026573265 |
| FEI number | 3026573265 |
At a glance
- 1–9 Supplements
- Oct 2, 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- No Withdrawn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: