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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 SALINE FILLED BREST IMPLANTS
Generic Nameprosthesis, breast, inflatable, internal, saline
Regulation Number878.3530
Applicant
Allergan
2525 dupont dr.
irvine, CA 92612
PMA NumberP990074
Supplement NumberS029
Date Received05/30/2014
Decision Date02/11/2015
Product Code FWM 
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A MANUFACTURING SITE LOCATED AT PRO-TECH DESIGN AND MANUFACTURING, INC., IN ARLINGTON, TEXAS.
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