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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameBIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Nameradiofrequency ablation catheter, electrode recording catheter
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP030031
Date Received07/28/2003
Decision Date11/05/2004
Product Code
OAD[ Registered Establishments with OAD ]
Docket Number 04M-0497
Notice Date 11/12/2004
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for for the navistar/ celsius thermocool deflectable diagnostic/ablation catheters, which include these models: navistar thermocool (models ns75t-bct-252-hs, ns75t-cct-252-hs, ns75t-dct-252-hs, ns75t-fct-252-hs, ns75tc-bct-252-hs, ns75tc-cct-252-hs, ns75tc-dct-252-hs, and ns75tc-fct-252-hs); and celsius thermocool (models d7it-bl-252-rt, d7it-dl-252-rt, d7it-fl-252-rt, d7itc-bl-252-rt, d7itc-dl-252-rt, and d7itc-fl-252-rt). The biosense webster navistar/celsius thermocool diagnostic/ablation deflectable tip catheters and related accessory devices are indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording), and when used with the stockert 70 generator, for the treatment of type i atrial flutter in patients age 18 or older. The navistar thermocool catheter provides location information when used with the carto ep/xp navigation system.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S018 S019 S020 S021 
S022 S023 S024 S026 S027 S028 S029 S030 S031 
S032 S033 S034 S035 S036 S037 S038 S039 S040 
S041 S042 S043 S045 S047 S048 S050 S051 S052 
S053 S054 S055 S057 S058 
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