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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
Applicant
Allergan
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 Product No
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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