|
Device | NAVISTAR RMT THERMOCOOL MAGNETIC STEERING CATHETERS |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P030031 |
Supplement Number | S036 |
Date Received | 10/19/2011 |
Decision Date | 12/12/2011 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR EXTENDING THE SHELF LIFE FROM ONE (1) TO THREE (3) YEARS AND FOR A MINOR CHANGE TO THE THERMOFOAM TRAY USED TO PACKAGE THE DEVICES. |