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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 NameMEDTRONIC 2030A BATTERYCHECK MONITOR TO BE USED WITH THE INSYNC II MARQUIS 7289, INSYNC MARQUIS MODEL 7277, MAXIMO DR...
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namecardiac resynchronization therapy
ApplicantMEDTRONIC VASCULAR
PMA NumberP010031
Supplement NumberS023
Date Received05/05/2005
Decision Date06/08/2005
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the medtronic 2030a batterycheck monitor to be used with the insync ii marquis 7289, insync marquis model 7277, maximo dr model 7278, maximo vr model 7232, marquis dr model 7274, and marquis vr model 7230.
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