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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 NameRELAY/DASH/STRIDE/DART PACING SYSTEMS
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator and programmer
Regulation Number870.3610
ApplicantINTERMEDICS, INC.
PMA NumberP910020
Supplement NumberS014
Date Received02/01/1996
Decision Date03/03/1996
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the introduction of labeling addressing compatibility of pacemakers with cellular telephones. Specifically the following models are affected:relay:293-03/294-03/294-03r -- dash:291-03/292-03/292-03r -- stride:294-05 -- dart:292-05 -- unity-c:292-06.
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