PMA P070004S031
- Device
- Sientra OPUS Silicone Gel Breast Implants
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P070004
- Supplement
- S031
- Product code
- FTR
- Decision date
- 2020-04-02
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- Add one (1) new vacuum pump and four (4) new vacuum chambers.
Current openFDA PMA Record#
- Device
- Sientra OPUS Silicone Gel Breast Implants
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P070004
- Supplement
- S031
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2020-04-02
- Decision code
- OK30
- Date received
- 2020-03-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add one (1) new vacuum pump and four (4) new vacuum chambers.