Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: BLAZER OPEN-IRRIGATED ABLATION CATHETER
• Generic Name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
• Applicant: Boston Scientific Corp.; 150 BAYTECH DRIVE; SAN JOSE, CA 95134
• PMA Number: P150005
• Date Received: 02/02/2015
• Decision Date: 02/24/2016
• Product Code: OAD
• Docket Number: 16M-0807
• Notice Date: 03/07/2016
• Advisory Committee: Cardiovascular
• Clinical Trials: NCT01253200
• Expedited Review Granted?: No
• Combination Product: No
• Recalls: CDRH Recalls

Approval Order Statement  
Approval for the Blazer Open-Irrigated Ablation Catheter, when used with a Maestro 4000 Radiofrequency (RF) Controller and MetriQ Irrigation Pump, is indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, and radiofrequency ablation of sustained or recurrent Type I Atrial Flutter (AFL) in patients age 18 or older.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Supplements: S009 S010 S006 S007 S008 S019 S020 S001 S002 S003 S004 ; S005 S022 S023 S014 S015 S016 S017 S018 S011 S012 S013 S021 ; S030 S031 S032 S046 S047 S054 S055 S042 S043 S044 S045 S067 ; S068 S061 S075 S076 S024 S025 S026 S035 S033 S034 S036 S037 ; S027 S028 S029 S038 S039 S040 S056 S048 S049 S050 S051 S052 ; S057 S058 S053 S041 S071 S072 S069 S070 S063 S077 S078 S074 ; S062 S073 S059 S060 S064 S065 S066 S080 S081 S082 S083