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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 NameAPSU PROGRAMMER, APSU SOFTWARE, BASE STATION
Classification Nameimplantable pacemaker pulse-generator
Generic Namecardiac pacemaker programmer and base station
Regulation Number870.3610
ApplicantST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
PMA NumberP880086
Supplement NumberS046
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 physican manuals specifying those cellular telephone protocols for which testing has been peroformed and shown no interaction.
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