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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.
 
DeviceNAVISTAR, 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 Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Applicant
BIOSENSE WEBSTER, INC.
3333 diamond canyon rd.
diamond bar, CA 91765
PMA NumberP010068
Supplement NumberS023
Date Received03/01/2011
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 - manufacturer/sterilizer/packager/supplier
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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