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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 MEDICAL SALINE-FILLED BREAST IMPLANTS
Classification Nameprosthesis, breast, inflatable, internal, saline
Generic Namesilicone inflatable breast prosthesis
Regulation Number878.3530
ApplicantALLERGAN
PMA NumberP990074
Supplement NumberS008
Date Received07/23/2001
Decision Date08/08/2001
Product Code
FWM[ Registered Establishments with FWM ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in manufacturing method. The change adds an alternative method for a casting process using the molding method of the style 68 saline-filled breast implant shell component used in the fabrication of saline-filled breast implants. There will be no changes to component specifications, designed performance specifications of the finished device, or to the pma designated physical and chemical specifications of the finished device.
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