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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 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 NumberS007
Date Received12/12/2013
Decision Date01/08/2014
Product Code FTR 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGES TO THE MATERIAL OF THE BREAST IMPLANT MOLDS.
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