|
Device | E P TECH EPT-1000 CARDIAC ABLATION SYSTEM |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P920047 |
Supplement Number | S009 |
Date Received | 10/15/1997 |
Decision Date | 04/06/1998 |
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 |
Approval Order Statement Approval for design modifications that provide for new circuitry to an accessory of the system (Automatic Personality Module) which permits filtering of electrograms during ablation. |