|
Device | EPT-1000 CARDIAC ABLATION SYSTEM |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 4100 Hamline Avenue North St Paul, MN 55112 |
PMA Number | P920047 |
Supplement Number | S017 |
Date Received | 08/07/2002 |
Decision Date | 09/27/2002 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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. |