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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 IPG
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator programming software
ApplicantMEDTRONIC VASCULAR
PMA NumberP980035
Supplement NumberS045
Date Received07/26/2005
Decision Date09/30/2005
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to verify additional programming parameters at the post-sterilization manufacturing step. The devices, as modified, will be marketed under the trade names entrust implantable cardioverter defibrillator and enrhythm implantable pulse generator respectively.
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