Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: Sientra Silicone Gel Breast Implants
• Generic Name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
• Regulation Number: 878.3540
• Applicant: Tiger Aesthetics Medical, LLC; 9779 S. Franklin Dr.; Suite 300; Franklin, WI 53132
• PMA Number: P070004
• Supplement Number: S039
• Date Received: 08/17/2023
• Decision Date: 07/16/2024
• Product Code: FTR
• Advisory Committee: General & Plastic Surgery
• Supplement Type: 135 Review Track For 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR THE SIENTRA SILICONE GEL BREAST IMPLANTS. THIS DEVICE IS INDICATED FOR: 1) BREAST AUGMENTATION FOR WOMEN AT LEAST 22 YEARS OLD. BREAST AUGMENTATION INCLUDES PRIMARY BREAST AUGMENTATION AS WELL AS REVISION SURGERY TO CORRECT OR IMPROVE THE RESULT OF PRIMARY BREAST AUGMENTATION SURGERY; AND 2) BREAST RECONSTRUCTION. BREAST RECONSTRUCTION INCLUDES PRIMARY RECONSTRUCTION TO REPLACE BREAST TISSUE THAT HAS BEEN REMOVED DUE TO CANCER OR TRAUMA OR THAT HAS FAILED TO DEVELOP PROPERLY DUE TO A SEVERE BREAST ABNORMALITY. BREAST RECONSTRUCTION ALSO INCLUDES REVISION SURGERY TO CORRECT OR IMPROVE THE RESULTS OF A PRIMARY BREAST RECONSTRUCTION SURGERY.