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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.
DeviceIntellaNav MiFi Open-Irrigated Ablation Catheter
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Boston Scientific Corp.
150 baytech drive
san jose, CA 95134
PMA NumberP150005
Supplement NumberS049
Date Received10/09/2019
Decision Date04/17/2020
Product Code OAD 
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the DirectSense RF feature in the Rhythmia HDx Mapping System Software Version 4.0 to be used in conjunction with the IntellaNav MiFi Open-Irrigated Ablation Catheter during cardiac ablation.