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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 NumberS020
Date Received09/16/2019
Decision Date10/15/2019
Product Code
FTR[ Registered Establishments with FTR ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of an additional snap gauge data input tool used to collect and document shell thickness measurements in manufacturing Sientra OPUS Silicone Gel Breast Implants.
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