PMA P070004S034

Device: Sientra OPUS Silicone Gel Breast Implants
Applicant: Tiger Aesthetics Medical, LLC
PMA number: P070004
Supplement: S034
Product code: FTR
Decision date: 2022-03-02
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Approval order statement: Addition of a gel dispersion viscosity assessment method, ‘Percent Solids Method’ to provide supplementary dispersion viscosity information during the manufacture of Sientra Silicone Gel Breast Implants.

Current openFDA PMA Record#

Device: Sientra OPUS Silicone Gel Breast Implants
Applicant: Tiger Aesthetics Medical, LLC
PMA number: P070004
Supplement: S034
Product code: FTR
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date: 2022-03-02
Decision code: OK30
Date received: 2022-01-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of a gel dispersion viscosity assessment method, ‘Percent Solids Method’ to provide supplementary dispersion viscosity information during the manufacture of Sientra Silicone Gel Breast Implants.