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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.
 
DeviceMODEL 9600 PROG.,1250H GENERATOR SOFTWARE V4.10UE
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
15900 Valley View Ct.
Sylmar, CA 91342
PMA NumberP900070
Supplement NumberS002
Date Received06/19/1992
Decision Date01/07/1993
Withdrawal Date 06/20/2007
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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