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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 NameMENTOR SALINE-FILLED MAMMARY PROSTHESES
Generic Namesaline-filled mammary prosthesis
ApplicantMENTOR CORP.
PMA NumberP990075
Supplement NumberS002
Date Received10/23/2000
Decision Date12/22/2000
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 an increased shell thickness of the contour tall profile styles 5000, 5000pt, 6000, and 6000pt.
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