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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 DS 8 MM DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER AND CELSIUS DS 8 MM DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER
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 NumberS004
Date Received07/28/2004
Decision Date09/10/2004
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternative sterilization method (i. E. , eo express for biological indicator release) for the navistar ds 8mm deflectable diagnostic/ablation catheter and celsius ds 8 mm deflectable diagnostic/ablation catheter.
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