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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.
 
DeviceABBOTT AXSYM/TOTAL PSA
Generic NamePROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
Regulation Number866.6010
ApplicantAbbott Laboratories
100 ABBOTT PARK RD.
ABBOTT PARK, IL 60064-3500
PMA NumberP910007
Supplement NumberS006
Date Received06/15/2001
Decision Date03/03/2004
Product Code LTJ 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT HEALTH PRODUCTS, INC., BARCELONETA, PUERTO RICO.
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