|
Device | EZ STEER NAV AND EZ STEER NAV DS CATHETERS |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P030031 |
Supplement Number | S021 |
Date Received | 10/09/2009 |
Decision Date | 12/14/2009 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR CHANGES TO THE CATHETER IFUS TO ALLOW FOR ADDITIONAL COMPATIBILITY WITH THE CARTO 3 SYSTEMS. |
Post-Approval Study | Show Report Schedule and Study Progress |