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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 NameNAVISTAR RMT THERMOCOOL DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER
Classification Namecardiac ablation percutaneous catheter
Generic Namedrf(21 cfr 870.1220)
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP040036
Supplement NumberS009
Date Received10/09/2008
Decision Date11/07/2008
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for two additional quality control inspection steps: 1) adding a 100% visual inspection of the pcb boards to verify that all components are present, and 2) adding an eeprom read step during the existing calibration process to verify that all pcb components are present and functioning properly.
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