HeartLight Endoscopic Ablation System

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

FDA Premarket Approval P150026 S004

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

Implement an automated label printing system for udi requirements.

• Device: HeartLight Endoscopic Ablation System
• Classification Name: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
• Generic Name: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
• Applicant: CARDIOFOCUS, INC.
• Date Received: 2018-04-04
• Decision Date: 2018-04-16
• PMA: P150026
• Supplement: S004
• Product Code: OAE
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: CARDIOFOCUS, INC. 500 Nickerson Road marlborough, MA 01752

Supplemental Filings

Supplement Number	Date	Supplement Type
P150026		Original Filing
S013	2022-03-04	Normal 180 Day Track
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
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 ID	PMA	Supp
00868976000178	P150026	000
00868976000161	P150026	000
00868976000154	P150026	000
00868976000130	P150026	000
00868976000123	P150026	000
00868976000116	P150026	000
00868976000109	P150026	000