PMA P070004S014
- Device
- Sientra OPUS Silicone Gel Breast Implants
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P070004
- Supplement
- S014
- Product code
- FTR
- Decision date
- 2018-01-19
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- Changes to sterilization equipment and dry heat sterilization cycle, and packaging features for Sientra OPUS Silicone Gel Breast Implants at the following manufacturing facility: Vesta, Inc., 9900 South 57th Street, Franklin, Wisconsin.
Current openFDA PMA Record#
- Device
- Sientra OPUS Silicone Gel Breast Implants
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P070004
- Supplement
- S014
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2018-01-19
- Decision code
- OK30
- Date received
- 2017-12-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to sterilization equipment and dry heat sterilization cycle, and packaging features for Sientra OPUS Silicone Gel Breast Implants at the following manufacturing facility: Vesta, Inc., 9900 South 57th Street, Franklin, Wisconsin.