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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® X3 Catheter with Excalibur Balloon™
Generic NameCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantCardiofocus, Inc.
500 Nickerson Rd.
Marlborough, MA 01752
PMA NumberP150026
Supplement NumberS013
Date Received03/04/2022
Decision Date04/02/2022
Product Code OAE 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at Sterigenics, Inc., 84 Park Road, Queensbury, NY 12804 as an alternate sterilization site for the HeartLight X3 Catheter with Excalibur Balloon.
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