PMA P070004S022
- Device
- Sientra OPUS Silicone Gel Breast Implants
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P070004
- Supplement
- S022
- Product code
- FTR
- Decision date
- 2019-10-29
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- Addition of a Variable Frequency Drive (VFD) to the Dipping Hood blower system used in the manufacturing of Sientra OPUS® Silicone Gel Breast Implants.
Current openFDA PMA Record#
- Device
- Sientra OPUS Silicone Gel Breast Implants
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P070004
- Supplement
- S022
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2019-10-29
- Decision code
- OK30
- Date received
- 2019-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a Variable Frequency Drive (VFD) to the Dipping Hood blower system used in the manufacturing of Sientra OPUS® Silicone Gel Breast Implants.