PMA P230005S005

Device: Motiva SmoothSilk® Round and Round Ergonomix® Silicone Gel-Filled Breast Implants
Applicant: Motiva USA, LLC
PMA number: P230005
Supplement: S005
Product code: FTR
Decision date: 2026-09-25
Classification: General, Plastic Surgery
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Approval order statement: adding an additional supplier for the shell patch and patch filler components

Current openFDA PMA Record#

Device: Motiva SmoothSilk® Round and Round Ergonomix® Silicone Gel-Filled Breast Implants
Applicant: Motiva USA, LLC
PMA number: P230005
Supplement: S005
Product code: FTR
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date: 2026-09-25
Decision code: APPR
Date received: 2026-04-02
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: adding an additional supplier for the shell patch and patch filler components