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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSALINE-FILLED MAMMARY PROSTHESIS - STYLES 5000 AND 5000PT AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY
Generic Namesaline-filled mammary prosthesis
ApplicantMENTOR CORP.
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 - specifications
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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