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 | INTELLANAV OPEN-IRRIGATED ABLATION CATHETER |
Generic Name | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P150005 |
Supplement Number | S005 |
Date Received | 04/11/2016 |
Decision Date | 07/07/2016 |
Product Code |
OAD |
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 design changes to incorporate a magnetic sensor into the Blazer Open Irrigated Ablation Catheter. The device, as modified, will be marketed under the trade name IntellaNav Open-Irrigated Ablation Catheter and is indicated for: The IntellaNav™ Open-Irrigated Catheter, when used with a Maestro 4000® Radiofrequency (RF) Controller and MetriQ™ Irrigation Pump, is indicated for:1) cardiac electrophysiological mapping; 2) delivering diagnostic pacing stimuli; and 3) RF ablation of sustained or recurrent type 1 atrial flutter in patients age 18 years or older. |
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