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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.
 
DeviceSALINE-FILLED & SPECTRUM BREAST IMPLANTS
Generic Nameprosthesis, breast, inflatable, internal, saline
Regulation Number878.3530
ApplicantMENTOR WORLDWIDE LLC
33 technology drive
irvine, CA 92618
PMA NumberP990075
Supplement NumberS022
Date Received02/11/2011
Decision Date10/08/2013
Product Code FWM 
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR UPDATED LABELING INCORPORATING INFORMATION ON ANAPLASTIC LARGE CELL LYMPHOMA (ALCL).
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