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Device | CHILLI COOLED RF ABLATION SYSTEM |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P980003 |
Date Received | 01/30/1998 |
Decision Date | 02/02/1999 |
Withdrawal Date | 02/28/2024 |
Product Code |
LPB |
Docket Number | 99M-2016 |
Notice Date | 06/28/1999 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | Yes |
Combination Product | No |
Predetermined Change Control Plan Authorized | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval for the Chili(R) Cooled Ablation System which includes: 1)Chili(R) Cooled Ablation Catheter, Standard Curve (Model 3005; 2)Chili(R) Cooled Ablation Catheter, Large Curve (Model 3006); RF Generator/Pump System (Model 8004); EGM Bypass Switch Box (model 2035); RF Filter Box (Model 2048); Chili(R) Tubing Kit (Model 2100); EGM/RF Generator Cable (Models 2001 and 2028); and EGM Generator Cable (Model 2002 and 2029). This device is indicated for cardiac electropysiological mapping, delivering diagnostic pacing stimuli, and radiofrequency ablation of mappable ventricular tachycardias attributable to ischemic heart disease or cardiomyopathy in patients who have failed drug therapy. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S005 S073 S076 S071 S086 S087 S012 S013 S008 S009 S010 S011 S019 S027 S024 S025 S026 S007 S065 S028 S029 S030 S031 S032 S033 S034 S035 S036 S046 S047 S048 S049 S050 S051 S052 S053 S054 S055 S056 S057 S058 S059 S061 S062 S063 S064 S066 S072 S037 S038 S039 S040 S041 S042 S043 S022 S045 S074 S075 S068 S069 S014 S015 S017 S016 S001 S002 S020 S004 S018 S021 S083 S091 S089 S093 S095 S079 S080 S081 S082 S085 S084 S077 S078 S090 S092 S088 S096 S094 S097 |