|
Device | NAVISTAR RMT THERMOCOOL |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P030031 |
Supplement Number | S018 |
Date Received | 09/28/2009 |
Decision Date | 11/25/2009 |
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 IN LABELING TO REMOVE A STATEMENT EXCLUDING USE WITH THE STEREOTAXIS CARDIODRIVE CATHETER ADVANCEMENT SYSTEM. |
Post-Approval Study | Show Report Schedule and Study Progress |