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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, CELSIUS, QWIKSTAR, EZ STEER BI-DIRECTIONAL, NAVISTAR RMT DUAL SENOR (8MM) DIAGNOSTIC/ABLATION DEFLECTABLE
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Nameradiofrequency ablation catheter; electrode recording catheter
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP010068
Supplement NumberS023
Date Received03/08/2011
Decision Date02/08/2012
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an increase in the number of allowed eto sterilization cycles, and a modification to the workmanship inspection performed by quality control.
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