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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 NumberS055
Date Received06/30/2000
Decision Date07/21/2000
Product Code
LWO[ Registered Establishments with LWO ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of header part number 149422-002 in the following pulse generators: prevail model 8085, preva sr model 8089, prodigy s model 8165, prodigy sr model 8161, thera-i s model 8965i, thera-i sr model 8961i, vitatron visa s model 115 and vitatron visa sr model 415.