HeartLight X3 Endoscopic Ablation System

FDA Premarket Approval P150026 S012

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.

Pre-market Approval Supplement Details

Approval for the additional of a silicone coating to the inside of the excalibur balloon

DeviceHeartLight X3 Endoscopic Ablation System
Generic NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Date Received2021-01-06
Decision Date2021-04-06
Product CodeOAE 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address CARDIOFOCUS, INC. 500 Nickerson Road marlborough, MA 01752

Supplemental Filings

Supplement NumberDateSupplement Type
P150026Original Filing
S012 2021-01-06 Normal 180 Day Track
S011 2020-06-01 Normal 180 Day Track No User Fee
S010 2020-01-22 30-day Notice
S009 2019-12-18 30-day Notice
S007 2019-08-13 Real-time Process
S006 2019-05-29 Special (immediate Track)
S005 2019-01-08 Normal 180 Day Track
S004 2018-04-04 30-day Notice
S003 2017-11-09 Real-time Process
S002 2017-08-09 Normal 180 Day Track
S001 2017-05-05 Real-time Process


Device IDPMASupp
00868976000178 P150026 000
00868976000161 P150026 000
00868976000154 P150026 000
00868976000130 P150026 000
00868976000123 P150026 000
00868976000116 P150026 000
00868976000109 P150026 000

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.