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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 Endoscopic Ablation System
Generic NameCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantCardiofocus, Inc.
500 Nickerson Rd.
Marlborough, MA 01752
PMA NumberP150026
Supplement NumberS006
Date Received05/29/2019
Decision Date06/24/2019
Product Code OAE 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a labeling change to add a contraindication.
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