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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 NameMCGHAN SALINE-FILLED BREAST IMPLANT
Classification Nameprosthesis, breast, inflatable, internal, saline
Generic Namesilicone inflatable breast prosthesis
Regulation Number878.3530
ApplicantINAMED CORPORATION
PMA NumberP990074
Supplement NumberS012
Date Received07/23/2002
Decision Date08/08/2002
Product Code
FWM[ Registered Establishments with FWM ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) design modifications to the patch configuration, 2) changes to the patch vulcanization process, and 3) changes to the valve vulcanization process.
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