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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 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 NumberS022
Date Received03/06/1998
Decision Date09/03/1998
Withdrawal Date06/20/2007
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
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 modifications to the approved labeling including the: addition of a "Cellular Tested" logo and associated language in the Patient and Physician manuals specifying those cellular telephone protocols for which testing has been performed and shown no interaction.
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