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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.
 
DeviceR5.111WE(REVISION OF R5.85WE)
Generic Nameimplantable pacemaker Pulse-generator
ApplicantSt. Jude Medical, Cardiac Rhythm Management Divisi
15900 Valley View Ct.
Sylmar, CA 91342
PMA NumberP900070
Supplement NumberS025
Date Received09/07/1999
Decision Date09/24/1999
Withdrawal Date06/20/2007
Product Codes DXY KRG 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Version R5.111WE programmer software for the Model 9602 Programmer.
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