Motiva SmoothSilk®Round; Round Ergonomix® Silicone Gel-Filled Breast Implants
FDA premarket approval P230005/S003 · decided 2025-12-17
Approval details
- PMA number
- P230005
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Motiva SmoothSilk®Round; Round Ergonomix® Silicone Gel-Filled Breast Implants
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Applicant
- Motiva USA, LLC
- Date received
- 2025-11-26
- Decision date
- 2025-12-17
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- FTR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Santa Barbara, CA
- Statement
- Motiva seeks approval for addition of a manufacturing site.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Motiva Flora SmoothSilk Tissue Expander (K211676) | Motiva USA, LLC | 2023-10-13 |
| Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix (K183163) | Motiva USA, LLC | 2019-02-05 |