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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.
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
3333 diamond canyon rd.
diamond bar, CA 91765
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
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 S025 S026 S027 S028 S029 S030 
S031 S032 S033 S034 S035 S036 S037 S038 S039 
S040 S041 S042 S043 S044 S045 S047 S048 S050 
S051 S052 S053 S054 S055 S057 S058 S059 S060 
S061 S062 S063 S064 S065 S066 S067 S068 S069 
S070 S071 S072 S073 S075 S076 S077 S078 S079