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EPT-1000 CARDIAC ABLATION SYSTEM

FDA premarket approval P920047/S017 · decided 2002-09-27

Approval details

PMA number
P920047
Supplement
S017
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
EPT-1000 CARDIAC ABLATION SYSTEM
Generic name
Cardiac ablation percutaneous catheter
Applicant
Boston Scientific Corp
Date received
2002-08-07
Decision date
2002-09-27
Days to decision
51 days
Decision code
APPR
Product code
LPB
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
APPROVAL FOR REVISED INDICATIONS FOR USE FOR THE STEEROCATH-T, POLARIS-T, AND BLAZER II ABLATION CATHETERS, WHICH ARE COMPONENTS OF THE EPT-1000 CARDIAC ABLATION SYSTEM. THE CATHETERS ARE INDICATED FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIA.

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510(k) clearances by this applicant

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XXL Vascular Balloon Dilatation Catheter (K150303)Boston Scientific Corp2015-06-15
Chariot Guiding Sheath (K150186)Boston Scientific Corp2015-06-05
EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679)Boston Scientific Corp2015-05-29
JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820)Boston Scientific Corp2014-10-21