|
Device | CHILLI COOLED ABLATION CATHETERS |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P980003 |
Supplement Number | S009 |
Date Received | 10/02/2003 |
Decision Date | 02/05/2004 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE USE OF THE CHILLI CATHETERS WITH THE EPT-1000 XP RF GENERATOR USING THE SAME MAXIMUM OUTPUT POWER AS THAT USED WITH THE MODEL 8004 AND EPT-1000 TC GENERATORS. |