Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone Gel-Filled Breas
FDA premarket approval P230005/S001 · decided 2024-11-22
Approval details
- PMA number
- P230005
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- 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
- Date received
- 2024-10-25
- Decision date
- 2024-11-22
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- FTR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Santa Barbara, CA
- Statement
- Approval of the protocol for the post-approval study (PAS)
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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 |