|
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 | S015 |
Date Received | 11/07/2001 |
Decision Date | 04/18/2002 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR NEW INDICATIONS FOR USE FOR ONE DEVICE COMPONENT OF THE EPT-1000 CARDIAC ABLATION SYSTEM. THE DEVICE COMPONENT, AS MODIFIED, WILL, BE MARKETED UNDER THE TRADE NAME EPT-1000 TC CARDIAC ABLATION CONTROLLER WITH TEMPERATURE CONTROL AND IS INDICATED FOR USE IN CONJUNCTION WITH THE APPROPRIATE RADIOFREQUENCY ABLATION CATHETER FOR CARDIAC ABLATION PROCEDURES. |