- Device
- Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone Gel-Filled Breas
- Applicant
- Motiva USA, LLC
- PMA number
- P230005
- Supplement
- S001
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2024-11-22
- Decision code
- APPR
- Date received
- 2024-10-25
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the protocol for the post-approval study (PAS)