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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
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 NumberS006
Date Received09/19/2013
Decision Date12/18/2013
Product Code
FTR[ Registered Establishments with FTR ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR ADDITIONAL IMPLANT STYLES THAT INCORPORATE CHANGES TO THE APPROVED PMA DEVICES AND INCLUDES THE FOLLOWING STYLES: 10610-LP; 10621-MP/HP; 10712-MP; 10722-HP; 20710-LP; 10710-LP; 20721-MP/HP; 10721-MP/HP; FIVE ADDITIONAL SIZES OF THE 10512-MP STYLE IMPLANT; FOUR ADDITIONAL SIZES OF THE 10521-HP STYLE IMPLANT; FOUR ADDITIONAL SIZES OF THE 20610-LP STYLE IMPLANT; AND EIGHT ADDITIONAL SIZES OF THE 20621-MP/HP STYLE IMPLANT.
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