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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 and HeartLight Console
Generic NameCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantCardiofocus, Inc.
500 Nickerson Rd.
Marlborough, MA 01752
PMA NumberP150026
Supplement NumberS011
Date Received06/01/2020
Decision Date07/01/2020
Product Code OAE 
Advisory Committee Cardiovascular
Clinical TrialsNCT03168659
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the protocol for the post-approval study (PAS) protocol.
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