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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 NameACTIVITRAX MODELS 8400, 8402, 8403
Classification Namepulse-generator, single chamber, sensor driven, implantable
Generic Namesingle chamber, sensor driven, implantable pulse g
Applicant MEDTRONIC INC.
PMA NumberP850051
Supplement NumberS014
Date Received03/23/1988
Decision Date04/21/1988
Product Code
LWO[ Registered Establishments with LWO ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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