PMA P230005S003
- Device
- Motiva SmoothSilk®Round; Round Ergonomix® Silicone Gel-Filled Breast Implants
- Applicant
- Motiva USA, LLC
- PMA number
- P230005
- Supplement
- S003
- Product code
- FTR
- Decision date
- 2025-12-17
- Classification
- General, Plastic Surgery
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- Motiva seeks approval for addition of a manufacturing site.
Current openFDA PMA Record#
- Device
- Motiva SmoothSilk®Round; Round Ergonomix® Silicone Gel-Filled Breast Implants
- Applicant
- Motiva USA, LLC
- PMA number
- P230005
- Supplement
- S003
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2025-12-17
- Decision code
- OK30
- Date received
- 2025-11-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Motiva seeks approval for addition of a manufacturing site.