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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.
 
DeviceDIMENSION PSA FLEX REAGENT CARTRIDGE
Generic NamePROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
Regulation Number866.6010
ApplicantSiemens Healthcare Diagnostics
500 Gbc Dr.
P.O. Box 6101
Newark, DE 19714
PMA NumberP000021
Supplement NumberS001
Date Received07/12/2001
Decision Date07/31/2001
Product Code LTJ 
Advisory Committee Immunology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF THE DIMENSION(R) PSA FLEX(R) REAGENT CARTRIDGE FOR USE WITH THE DIMENSION(R) XPAND(TM) SYSTEM.
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