HeartLight Catheter and HeartLight Console

FDA Premarket Approval P150026 S011

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 of the protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p150026/s008.

DeviceHeartLight Catheter and HeartLight Console
Generic NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
ApplicantCARDIOFOCUS, INC.
Date Received2020-06-01
Decision Date2020-07-01
PMAP150026
SupplementS011
Product CodeOAE 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Ode/oir
Expedited ReviewNo
Combination Product No
Applicant Address CARDIOFOCUS, INC. 500 Nickerson Road marlborough, MA 01752

Supplemental Filings

Supplement NumberDateSupplement Type
P150026Original Filing
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
S008
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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