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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 NameENPULSE IMPLANTABLE PULSE GENERATOR, MODELS E1DR01, E1DR03, E1DR06, E1DR21 AND MODEL 9991 V 2.0 APPLICATION SOFTWARE
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pulse generator programming software
Regulation Number870.3610
ApplicantMEDTRONIC VASCULAR
PMA NumberP980035
Supplement NumberS036
Date Received03/02/2004
Decision Date03/31/2004
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the atrial capture management (acm) and post mode switch overdrive pacing (pmop) features to enpulse implantable pulse generator models e1dr01, e1dr03, e1dr06, and e1dr21. In addition, you requested approval for minor updates to the associated programmer software. The device, as modified, will be marketed under the trade name enpulse implantable pulse generator models e1dr01, e1dr03, e1dr06, e1dr21 and model 9991 v 2. 0 application software.
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