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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.
 
DeviceTEMPO FAMILY OF PULSE GENERATORS
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 NumberS024
Date Received10/06/1998
Decision Date10/29/1998
Withdrawal Date06/20/2007
Product Code DXY 
Advisory Committee Cardiovascular
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 an extension of product shelf life from 12 months to 18 months.
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