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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.
Classification Namepulse-generator, single chamber, sensor driven, implantable
Generic Namesingle chamber, sensor driven, implantable pulse
PMA NumberP850051
Supplement NumberS051
Date Received07/10/1995
Decision Date10/31/1995
Product Code
LWO[ Registered Establishments with LWO ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of three models of pulse generators to your activitrax cardiac pacing system. The devices will be marketed under the trade naem of prevail (models 8084, 8085, and 8086) using model 9885e software with the already approved programmers models 9760 and 9790, and momorymod model 9773 for use with the already approved model 9710a programmer.