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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 3307 V1.2A PROGRAMMER SOFTWARE FOR THE MODEL 3500/3510 PROGRAMMERS
Generic NameProgrammer, pacemaker
Regulation Number870.3700
ApplicantSt. Jude Medical, Inc.
15900 VALLEY VIEW Court
SYLMAR, CA 91342
PMA NumberP830045
Supplement NumberS070
Date Received05/25/2000
Decision Date06/26/2000
Withdrawal Date 06/20/2007
Product Code KRG 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODEL 3307 V1.2A PROGRAMMER SOFTWARE FOR THE MODEL 3500/3510 PROGRAMMERS.
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