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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 - STYLES 5000 AND 5000PT AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY
Applicant
MENTOR WORLDWIDE LLC
33 technology drive
irvine, CA 92618
PMA NumberP990075
Supplement NumberS004
Date Received07/10/2001
Decision Date09/05/2001
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR 1) AN INCREASE IN THE THICKNESS OF THE SHELL RADIUS/BASE FOR STYLE 5000PT AND 2) A DECREASE IN THICKNESS OF THE TEXTURED LAYER FROM 0.02" TO 0.01" FOR STYLES 5000, 5000PT, 6000 AND 6000PT. THE SECOND CHANGE EFFECTIVELY WITHDRAWS THE APPROVED CHANGE IN SUPPLEMENT 2.
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