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 MiFi 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 | S017 |
Date Received | 03/16/2017 |
Decision Date | 08/22/2017 |
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 the IntellaNav MiFi Open-Irrigated Ablation Catheter, which represents design, manufacturing, and labeling changes to the IntellaTip MiFi Open-Irrigated Ablation Catheter |
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