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Device | NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER |
Generic Name | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P010068 |
Date Received | 12/31/2001 |
Decision Date | 09/27/2002 |
Product Code |
OAD |
Docket Number | 03M-0049 |
Notice Date | 02/10/2003 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | No |
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 |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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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 S031 S032 S033 S034 S035 S036 S037 S038 S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 S051 S052 S053 S054 S055 S056 S057 S058 S059 S060 S061 S062 S063 S064 S065 S066 S067 S068 S069 S070 S071 |