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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 NameMERIDIAN AND DISCOVERY PACEMAKER SYSTEMS
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namedual-chamber adaptive-rate pacemaker
ApplicantGUIDANT CORP.
PMA NumberP940031
Supplement NumberS015
Date Received07/01/1998
Decision Date07/24/1998
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to the specification of the "runaway" rate for the above referenced families of pacemakers from 220+10% to 205+5%.
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