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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 BREAST IMPLANTS
Classification Nameprosthesis, breast, noninflatable, internal, silicone gel-filled
Generic Nameprosthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Number878.3540
Applicant
Allergan
2525 dupont dr.
irvine, CA 92612
PMA NumberP040046
Supplement NumberS013
Date Received12/30/2014
Decision Date08/05/2015
Product Code
FTR[ Registered Establishments with FTR ]
Advisory Committee General & Plastic Surgery
Clinical Trials NCT01785069
Supplement Typenormal 180 day track
Supplement Reason other report
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR TWENTY-EIGHT (28) ADDITIONAL NATRELLE 410 DEVICES THAT INCLUDE: FOUR (4) SIZES OF STYLE FL 410; FOUR (4) SIZES OF STYLE ML 410; ONE (1) SIZE OF STYLE LM 410; THREE (3) SIZES OF STYLE LL 410; TWO (2) SIZES OF STYLE LF 410; FOUR (4) SIZES OF STYLE FX 410; FOUR (4) SIZES OF STYLE MX 410; AND SIX (6) SIZES OF STYLE LX 410. THESE TWENTY-EIGHT (28) ADDITIONAL NATRELLE 410 DEVICES ENCOMPASS A RANGE OF: VOLUME = 140-775 CC; WIDTH = 9.5-15.5 CM; HEIGHT = 7.6-16.0 CM; AND PROJECTION = 2.9-7.1 CM.
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