- Device
- Sientra OPUS Silicone Gel Breast Implants
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P070004
- Supplement
- S035
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2022-07-05
- Decision code
- APPR
- Date received
- 2022-04-08
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the Low Profile Plus projection style to the current portfolio of Sientra Silicone Gel Breast Implants.