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: STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR
• Generic Name: Cardiac ablation percutaneous catheter
• Applicant: Biosense Webster, Inc.; 31 Technology Dr., Suite 200; Irvine, CA 92618
• PMA Number: P990071
• Date Received: 11/09/1999
• Decision Date: 05/31/2000
• Product Code: LPB
• Docket Number: 03M-0045
• Notice Date: 03/01/2003
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No
• Recalls: CDRH Recalls

Approval Order Statement  
THE STOCKERT 70 RF GENERATOR SYSTEM IS INDICATED FOR USE WITH A BIOSENSE WEBSTER DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER TO DELIVER RF ENERGY DURING CARDIAC ABLATION PROCEDURES.

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