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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 NumberS010
Date Received11/14/2001
Decision Date12/12/2001
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  
ELIMINATION OF DESTRUCTIVE FINISHED PRODUCT RELEASE TESTING (FPRT) BASED ON AN ASSESSMENT OF THE CRITICAL CONTROL POINTS OF THE MANUFACTURING PROCESS BY THE HAZARD ANALYSIS CRITICAL CONTROL POINT (HACCP) METHOD.
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