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 | Heart Light Catheter with Excalibur Balloon |
Generic Name | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
Applicant | CARDIOFOCUS, INC. 500 NICKERSON ROAD MARLBOROUGH, MA 01752 |
PMA Number | P150026 |
Supplement Number | S002 |
Date Received | 08/09/2017 |
Decision Date | 05/02/2018 |
Product Code |
OAE |
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 HeartLight Endoscopic Ablation System with Excalibur Balloon, which represents design and labeling changes to the HeartLight Endoscopic Ablation System, including changes to the balloon component and cooling loop, and the addition of a balloon remote. |
Post-Approval Study | Show Report Schedule and Study Progress |
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