PMA P070004S045
- Device
- Sientra Silicone Gel Breast Implants
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P070004
- Supplement
- S045
- Product code
- FTR
- Decision date
- 2025-11-20
- Classification
- General, Plastic Surgery
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- approval for a change to the releasing agent for Sientra Silicone Gel Breast Implants
Current openFDA PMA Record#
- Device
- Sientra Silicone Gel Breast Implants
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P070004
- Supplement
- S045
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2025-11-20
- Decision code
- APPR
- Date received
- 2024-07-23
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a change to the releasing agent for Sientra Silicone Gel Breast Implants