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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 DS DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Nameradiofrequency ablation catheter; electrode recording catheter
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP010068
Supplement NumberS013
Date Received10/09/2008
Decision Date11/07/2008
Product Code
OAD[ Registered Establishments with OAD ]
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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