|
Device | EZ STEER THERMOCOOL NAV CATHETER |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P030031 |
Supplement Number | S022 |
Date Received | 11/17/2009 |
Decision Date | 07/07/2010 |
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 MODIFICATIONS TO THE CATHETERS TO MAKE THEM COMPATIBLE WITH THE CARTO 3 ELECTROANATOMIC NAVIGATION SYSTEM, AND THE ADDITION OF TWO RING ELECTRODES FOR SHAFT VISUALIZATION ON CARTO 3. |