|
Device | NAVISTAR RMT THERMOCOOL CATHETER |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P030031 |
Supplement Number | S019 |
Date Received | 10/01/2009 |
Decision Date | 12/07/2009 |
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 DESIGN MODIFICATIONS REMOVING CARTO RMT CONNECTIVITY FROM THE NAVISTAR RMT THERMOCOOL CATHETER HANDLE, RESULTING IN THE CELSIUS RMT THERMOCOOL CATHETER. |