|
Device | EPT-1000 TC CARDIAC ABLATION SYSTEM WITH TEMPERATURE CONTROL |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P920047 |
Supplement Number | S001 |
Date Received | 11/17/1994 |
Decision Date | 11/08/1995 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR AN ALTERNATE CONFIGURATION OF THE EPT-1000 CARDIAC ABLATION CONTROLLER WHICH INCORPORATES A TEMPERATURE CONTROL FEATURE |