| 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. |
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| Trade Name | BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS |
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| Classification Name | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
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| Generic Name | radiofrequency ablation catheter, electrode recording catheter |
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| Applicant | BIOSENSE WEBSTER, INC. |
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| PMA Number | P030031 |
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| Date Received | 07/28/2003 |
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| Decision Date | 11/05/2004 |
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| Product Code | |
| Docket Number | 04M-0497 |
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| Notice Date | 11/12/2004 |
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| Advisory Committee |
Cardiovascular |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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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
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| Post-Approval Study | Show 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
S051 |
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