HeartLight Endoscopic Ablation System

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Premarket Approval P150026 S007

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 a material change in a component of the catheter

DeviceHeartLight Endoscopic Ablation System
Classification NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Generic NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
ApplicantCARDIOFOCUS, INC.
Date Received2019-08-13
Decision Date2019-11-08
PMAP150026
SupplementS007
Product CodeOAE
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
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
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

NIH GUDID Devices

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

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