PMA P070004S037

Device: Sientra OPUS® Silicone Gel Breast Implants
Applicant: Tiger Aesthetics Medical, LLC
PMA number: P070004
Supplement: S037
Product code: FTR
Decision date: 2022-07-20
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Approval order statement: Changes to the environmental monitoring plan for both viable and non-viable particulates in Sientras manufacturing cleanroom, located in Franklin, Wisconsin.

Current openFDA PMA Record#

Device: Sientra OPUS® Silicone Gel Breast Implants
Applicant: Tiger Aesthetics Medical, LLC
PMA number: P070004
Supplement: S037
Product code: FTR
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date: 2022-07-20
Decision code: OK30
Date received: 2022-06-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Changes to the environmental monitoring plan for both viable and non-viable particulates in Sientras manufacturing cleanroom, located in Franklin, Wisconsin.