|
Device | NAVISTAR RMT THERMOCOOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P030031 |
Supplement Number | S005 |
Date Received | 03/30/2007 |
Decision Date | 01/04/2008 |
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 MODIFICATIONS TO THE NAVISTAR THERMOCOOL CATHETER DESIGN SO THAT IT IS COMPATIBLE WITH THE STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM. |