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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.
 
DeviceNATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS
Generic NameProsthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Number878.3540
ApplicantAllergan
2525 DUPONT DR.
IRVINE, CA 92612
PMA NumberP040046
Supplement NumberS008
Date Received08/11/2014
Decision Date11/07/2014
Product Code FTR 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR ADDITIONAL NATRELLE 410 DEVICE STYLES AND SIZES INCLUDING: ONE (1) SIZE OF STYLE FL 410; ONE (1) SIZE OF STYLE ML 410; TWO (2) SIZES OF STYLE LL 410; FOUR (4) SIZES OF STYLE LM 410; TEN (10) SIZES OF STYLE LF 410; NINE (9) SIZES OF STYLE FX 410; NINE (9) SIZES OF STYLE MX 410; AND SEVEN (7) SIZES OF STYLE LX 410.
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