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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
Classification Nameprosthesis, breast, inflatable, internal, saline
Generic Namementor saline-filled breast implants
Regulation Number878.3530
ApplicantMENTOR CORP.
PMA NumberP990075
Supplement NumberS014
Date Received11/20/2003
Decision Date01/16/2004
Product Code
FWM[ Registered Establishments with FWM ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revised labeling that reflects 7-year post-approval study data.
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