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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceSilicone Gel Breast Implants
Generic NameProsthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Number878.3540
ApplicantSIENTRA, INC
6769 HOLLISTER AVENUE
SUITE 201
SANTA BARBARA, CA 93117
PMA NumberP070004
Supplement NumberS019
Date Received08/20/2019
Decision Date12/18/2019
Product Code FTR 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changes to the quality acceptance criteria used in the manufacturing process of Sientra OPUS Silicone Gel Breast Implants
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