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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 NumberS016
Date Received07/01/2005
Decision Date07/27/2005
Product Code
FWM[ Registered Establishments with FWM ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) new style 2000 moderate plus profile, which is considered a modification to the existing product ine, with sizes 175cc-800cc; 2) additional sizes of 400cc, 450cc, 500cc, 600cc, 650cc and 800cc for style 1600; and 3) additional sizes of 350cc, 400cc, 700cc, 770cc, and 800cc for style 3000. There are no changes to the indications for use.
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