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| Trade Name | NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER |
| Classification Name | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
| Generic Name | radiofrequency ablation catheter; electrode recording catheter |
| Applicant | BIOSENSE WEBSTER, INC. |
| PMA Number | P010068 |
| Date Received | 12/31/2001 |
| Decision Date | 09/27/2002 |
| Product Code | |
| Docket Number | 03M-0049 |
| Notice Date | 02/10/2003 |
| Advisory Committee |
Cardiovascular |
| Expedited Review Granted? | No |
| Combination Product |
No
|
| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
Approval Order Statement Approval for the navistar ds and celsius ds diagnostic/ablation catheters, stockert 70 generator and accessories. The navistar ds and celsius ds catheters and related accessory devices are indicated for catheter-based cardiac electrophysiological mapping (stimulation and recording), and for use with the stockert 70 (model s7001 with software version 001/033) for the treatment of type i atrial flutter in patients age 18 or older. The navistar ds catheter provides location information when used with the carto ep navigation system. |
| Approval Order |
Approval Order
|
| Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 S027 S028 S029 S030 S033 |