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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
Classification Nameprosthesis, breast, noninflatable, internal, silicone gel-filled
Generic Nameprosthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Number878.3540
Applicant
SIENTRA, INC
6769 hollister avenue
suite 201
santa barbara, CA 93117
PMA NumberP070004
Supplement NumberS010
Date Received06/05/2017
Decision Date12/01/2017
Product Code
FTR[ Registered Establishments with FTR ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a trade name change from Sientra Silicone Gel Breast Implants to Sientra OPUS™ Silicone Gel Breast Implants.
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