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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 Namecardiac ablation percutaneous catheter
Generic Namerf ablation system
PMA NumberP980003
Supplement NumberS025
Date Received11/02/2010
Decision Date04/08/2011
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for ten design changes to the circucool model 8005 pump system to address stoppage and motor noise complaints. These changes include: 1) changing a schotky diode from on semiconductor¿s 1n5822 (40v maximum reverse voltage) to on semiconductor¿s mbr360 (60v maximum reverse voltage). 2) addition of a 33. 3v voltage suppressor (on semiconductor p6ke39ag) across motor terminals at the motor. 3) dimensional and tolerance revisions to the roller sleeve, shaft rotor and roller components.