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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 NumberS014
Date Received12/21/2017
Decision Date01/19/2018
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 
Changes to sterilization equipment and dry heat sterilization cycle, and packaging features for Sientra OPUS Silicone Gel Breast Implants at the following manufacturing facility: Vesta, Inc., 9900 South 57th Street, Franklin, Wisconsin.
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