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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
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 NumberS005
Date Received01/02/2014
Decision Date09/19/2014
Product Code
FTR[ Registered Establishments with FTR ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - pas
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR LABELING DOCUMENTS FOR THE NATRELLE® 410 HIGHLY COHESIVEANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS CONTAINING 10-YEAR DATA FROM THE FINAL POSTAPPROVAL STUDY REPORT.
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