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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 BREAST IMPLANTS
Generic NameProsthesis, breast, inflatable, internal, saline
Regulation Number878.3530
ApplicantAllergan
2525 Dupont Dr.
Irvine, CA 92612
PMA NumberP990074
Supplement NumberS028
Date Received12/31/2013
Decision Date03/27/2014
Product Code FWM 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE TO THE MATERIAL USED FOR THE FILL TUBE TIP ANDLUER ADAPTER OF THE FILL TUBE ASSEMBLY FOR NATRELLE SALINE-FILLED BREAST IMPLANTS FROM PRO-FAX PD626 POLYPROPYLENE HOMOPOLYMER TO P5M6K-080 POLYPROPYLENE COPOLYMER.
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