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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 ROAD
MARLBOROUGH, MA 01752
PMA NumberP150026
Supplement NumberS003
Date Received11/09/2017
Decision Date01/17/2018
Product Code OAE 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for an alternate sterilization process STERRAD 100NX to the current STERRAD NX process for endoscope sterilization.
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