|
Device | THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATIONAL CATHETER |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P030031 |
Supplement Number | S065 |
Date Received | 12/10/2014 |
Decision Date | 03/18/2015 |
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 MODIFICATION OF THE THERMOCOOL SMARTTOUCH SHAFT AND SENSOR. |