|
Device | NAVISTAR THERMOCOOL |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P040036 |
Supplement Number | S043 |
Date Received | 05/23/2014 |
Decision Date | 08/01/2014 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR UPDATES TO THE INSTRUCTIONS FOR USE OF THE POST APPROVAL STUDY RESULTS ON THE NAVISTAR THERMOCOOL CATHETER FOR VT CONDITION. |