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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 NumberS026
Date Received05/20/2013
Decision Date06/12/2013
Product Code FWM 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ALLERGAN COSTA RICA FACILITY ADD MANUFACTURING SPACE (FLOOR SPACE) TO ITS PRODUCTION AREA IN THE SHELL SOAKING AND SCRUBBING ROOM (ROOM 2) AND GOWNING ROOM (ROOM 3) AND NEW HEPA FILTERS TO ROOM 2.
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