PMA P070004S012
- Device
- Sientra Silicone Breast Implants
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P070004
- Supplement
- S012
- Product code
- FTR
- Decision date
- 2018-01-10
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- Change in the implant marking process.
Current openFDA PMA Record#
- Device
- Sientra Silicone Breast Implants
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P070004
- Supplement
- S012
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2018-01-10
- Decision code
- OK30
- Date received
- 2017-12-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the implant marking process.