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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameTEMPO PULSE GENERATORS
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse generator
Regulation Number870.3610
ApplicantPACESETTER, INC.
PMA NumberP900070
Supplement NumberS022
Date Received03/06/1998
Decision Date09/03/1998
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - performance characteristics
Expedited Review Granted? No
Combination Product No
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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