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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
ApplicantTiger Aesthetics Medical, LLC
9779 S. Franklin Dr.
Suite 300
Franklin, WI 53132
PMA NumberP070004
Supplement NumberS016
Date Received01/18/2019
Decision Date01/03/2023
Product Code FTR 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for revisions to the labeling to include the 10 year clinical study results.
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