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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.
 
DeviceHeartLight Catheter, HeartLight X3 Console V2
Generic NameCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantCardiofocus, Inc.
500 Nickerson Rd.
Marlborough, MA 01752
PMA NumberP150026
Supplement NumberS014
Date Received04/22/2022
Decision Date02/24/2023
Product Code OAE 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changes to the Console of the HeartLight System.
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