Premarket Approval (PMA)

Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.

• Trade Name: EPT-1000 CARDIAC ABLATION SYSTEM
• Classification Name: cardiac ablation percutaneous catheter
• Generic Name: cardiac ablation
• Applicant: BOSTON SCIENTIFIC CORP.
• PMA Number: P920047
• Date Received: 09/28/1992
• Decision Date: 10/28/1994
• Product Code: LPB [ Registered Establishments with LPB ]
• Docket Number: 95M-0121
• Notice Date: 06/07/1995
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 

• Supplements: S001 S002 S003 S004 S005 S006 ; S007 S008 S009 S010 S012 S013 ; S014 S015 S016 S017 S018 S019 ; S020 S021 S022 S023 S024 S025 ; S026 S027 S028 S029 S030 S031 ; S034 S035 S036 S037 S038 S039 ; S040 S041 S042 S043 S044 S045 ; S046 S047 S048 S049 S050 S051 ; S052 S053 S054 S055 S056 S057