Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | EZ STEER THERMOCOOL AND |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P040036 |
Supplement Number | S006 |
Date Received | 11/23/2007 |
Decision Date | 09/30/2008 |
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 INCORPORATION OF A BIDIRECTIONAL DEFLECTION MECHANISM IN THE NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL CATHETERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EZ STEER THERMOCOOL AND EZ STEER THERMOCOOL NAV CATHETERS AND INDICATED FOR TREATMENT OF TYPE I ATRIAL FLUTTER AND RECURRENT DRUG/DEVICE REFRACTORY SUSTAINED MONOMORPHIC VENTRICULAR TACHYCARDIA. |
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