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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 RTV SALINE-FILLED BREAST IMPLANTS - STYLES 68, 163, 168, 363 AND 468
Generic NameProsthesis, breast, inflatable, internal, saline
Regulation Number878.3530
ApplicantAllergan
2525 DUPONT DR.
IRVINE, CA 92612
PMA NumberP990074
Supplement NumberS009
Date Received08/31/2001
Decision Date09/21/2001
Product Code FWM 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO ADD MECHANICAL TESTING OF SAMPLE SHELLS PRODUCED AS PART OF THE INCOMING INSPECTION PROCESS FOR THE RTV SILICONE DISPERSION. THIS TESTING SERVES AS AN ADDITIONAL CRITERION FOR THE ACCEPTANCE OF THE RAW MATERIAL USED TO MAKE ALL STYLES OF THE SALINE-FILLED BREAST IMPLANTS.
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