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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 NumberS012
Date Received03/04/1998
Decision Date03/27/1998
Product Code
LWP[ Registered Establishments with LWP ]
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 design modifications related to the pacemaker top ("header") (including the lead connector, outer sleeve, anchor brackets, x-ray identifier, and laser mark), the sterile tray, and labeling changes to the physician's system manual and outer box labels of the vigor models 950, 1230, and 1232.
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