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Device | NAVISTAR® THERMOCOOL® DIAGNOSTIC/ABLATION CATHETER AND CELSIUS® THERMOCOOL® DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P030031 |
Supplement Number | S041 |
Date Received | 04/16/2012 |
Decision Date | 03/07/2013 |
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 OF MODIFICATIONS TO THE STOCKERT70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION AND COOLFLOW® IRRIGATION PUMP AS AN INTEGRATED SYSTEM. |