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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 NameAT500 DDDRP PACING SYSTEM (MODEL AT500) AND MODEL 9968 SOFTWARE POST-MARKET (RESPECT): ADDING THE ENRHYTHM MODEL P1501DR
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pulse generator programming software
Regulation Number870.3610
ApplicantMEDTRONIC VASCULAR
PMA NumberP980035
Supplement NumberS041
Date Received01/27/2005
Decision Date06/20/2005
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add the enrhythm model p1501dr to the post-approval study of the device.
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