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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceHeart Light Catheter with Excalibur Balloon
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Applicant
CARDIOFOCUS, INC.
500 nickerson road
marlborough, MA 01752
PMA NumberP150026
Supplement NumberS002
Date Received08/09/2017
Decision Date05/02/2018
Product Code
OAE[ Registered Establishments with OAE ]
Advisory Committee Cardiovascular
Supplement Typenormal 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 StudyShow Report Schedule and Study Progress
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