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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.
 
DeviceSientra OPUS Silicone 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 NumberS033
Date Received08/06/2021
Decision Date10/27/2021
Product Code FTR 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changes to the patient and physician labeling including a boxed warning and a patient decision checklist.
Approval OrderApproval Order
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