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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMCGHAN MEDICAL SALINE-FILLED BREAST IMPLANTS
Generic NameProsthesis, breast, inflatable, internal, saline
Regulation Number878.3530
ApplicantAllergan
2525 DUPONT DR.
IRVINE, CA 92612
PMA NumberP990074
Supplement NumberS008
Date Received07/23/2001
Decision Date08/08/2001
Product Code FWM 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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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