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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 AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS
Generic Namesaline-filled mammary prosthesis
ApplicantMENTOR CORP.
PMA NumberP990075
Supplement NumberS001
Date Received06/08/2000
Decision Date02/27/2001
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the mentor saline and spectrum mammary prostheses retrieval protocol.
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