PMA P070004S047
- Device
- Sientra Silicone Gel Breast Implants
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P070004
- Supplement
- S047
- Product code
- FTR
- Decision date
- 2025-07-24
- Classification
- General, Plastic Surgery
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- Risk assessment for raw material processing change (i.e. filter change) was determined to be adequate.
Current openFDA PMA Record#
- Device
- Sientra Silicone Gel Breast Implants
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P070004
- Supplement
- S047
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2025-07-24
- Decision code
- OK30
- Date received
- 2025-06-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Risk assessment for raw material processing change (i.e. filter change) was determined to be adequate.