PMA P230005S002

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: S002
Product code: FTR
Decision date: 2026-10-02
Classification: General, Plastic Surgery
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Approval order statement: Approval for the product line extension to smaller size devices

Current openFDA PMA Record#

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: S002
Product code: FTR
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date: 2026-10-02
Decision code: APPR
Date received: 2025-06-05
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the product line extension to smaller size devices