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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 MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS
Generic Nameprosthesis, breast, inflatable, internal, saline
Regulation Number878.3530
Applicant
MENTOR WORLDWIDE LLC
33 technology drive
irvine, CA 92618
PMA NumberP990075
Supplement NumberS016
Date Received06/27/2005
Decision Date07/27/2005
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 1) NEW STYLE 2000 MODERATE PLUS PROFILE, WHICH IS CONSIDERED A MODIFICATION TO THE EXISTING PRODUCT INE, WITH SIZES 175CC-800CC; 2) ADDITIONAL SIZES OF 400CC, 450CC, 500CC, 600CC, 650CC AND 800CC FOR STYLE 1600; AND 3) ADDITIONAL SIZES OF 350CC, 400CC, 700CC, 770CC, AND 800CC FOR STYLE 3000. THERE ARE NO CHANGES TO THE INDICATIONS FOR USE.
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