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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 NameENRHYTHM P1501 DR
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator programming software
PMA NumberP980035
Supplement NumberS081
Date Received11/16/2007
Decision Date12/04/2007
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor design changes that add two alternate tantalum capacitors (xtc017, xtc018) with increased voltage ratings to approved device components. The design modifications are intended to reduce manufacturing yield loss and associated rework.