Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone Gel-Filled Breas
FDA premarket approval P230005 · decided 2024-09-26
Approval details
- 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
- Date received
- 2023-02-24
- Decision date
- 2024-09-26
- Days to decision
- 580 days
- Decision code
- APPR
- Product code
- FTR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Santa Barbara, CA
- Statement
- The Motiva SmoothSilk Round and SmoothSilk Round Ergonomix breast implants are indicated for breast augmentation for women of at least 22 years old. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of an original primary breast augmentation surgery (i.e., revision-augmentation).
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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 |