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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.
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
8200 coral sea street ne
ms mv s11
mounds view, MN 55112
PMA NumberP990001
Supplement NumberS004
Date Received05/17/2000
Decision Date11/13/2000
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the dema pacing system and the citatron application software model vsa02, version 6. The dema pacing system consists of the following pulse generators: clarity ddr models 860, 862, 865; clarity ssir models 560, 562, 565; diamond 3 model 840; ruby 3 model 740; topaz 3 model 540; jade 3 model 340; vita 2 ddr model 830; vita 2 model 530.