EPT-1000 CARDIAC ABLATION SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Premarket Approval P920047

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

• Device: EPT-1000 CARDIAC ABLATION SYSTEM
• Classification Name: Cardiac Ablation Percutaneous Catheter
• Generic Name: Cardiac Ablation Percutaneous Catheter
• Applicant: Boston Scientific Corp.
• Date Received: 1992-09-28
• Decision Date: 1994-10-28
• Notice Date: 1995-06-07
• PMA: P920047
• Supplement: S
• Product Code: LPB
• Docket Number: 95M-0121
• Advisory Committee: Cardiovascular
• Expedited Review: No
• Combination Product: No
• Applicant Address: Boston Scientific Corp. 150 Baytech Drive san Jose, CA 95134

Supplemental Filings

Supplement Number	Date	Supplement Type
P920047		Original Filing
S129	2022-10-17	30-day Notice
S128	2022-08-22	30-day Notice
S127	2022-01-28	30-day Notice
S126	2022-01-24	30-day Notice
S125	2021-08-13	30-day Notice
S124	2020-12-18	Normal 180 Day Track
S123	2020-03-30	Real-time Process
S122	2020-03-12	Normal 180 Day Track No User Fee
S121	2020-01-22	30-day Notice
S120	2020-01-15	30-day Notice
S119	2019-11-22	Real-time Process
S118	2019-10-10	30-day Notice
S117	2019-08-09	30-day Notice
S116	2019-04-12	Real-time Process
S115	2019-04-08	30-day Notice
S114	2019-03-21	30-day Notice
S113	2018-10-30	30-day Notice
S112	2018-10-25	135 Review Track For 30-day Notice
S111	2018-08-24	30-day Notice
S110	2018-06-21	Normal 180 Day Track
S109	2018-06-13	30-day Notice
S108	2018-04-06	135 Review Track For 30-day Notice
S107	2018-01-17	30-day Notice
S106	2017-10-30	30-day Notice
S105	2017-10-02	30-day Notice
S104	2017-09-29	Normal 180 Day Track
S103	2017-09-14	30-day Notice
S102	2017-08-30	30-day Notice
S101	2017-08-04	30-day Notice
S100	2017-07-18	30-day Notice
S099	2017-06-26	30-day Notice
S098	2017-04-27	Real-time Process
S097	2017-04-13	30-day Notice
S096	2017-03-06	30-day Notice
S095	2016-11-22	30-day Notice
S094	2016-07-21	30-day Notice
S093
S092	2016-05-11	Real-time Process
S091	2016-04-15	135 Review Track For 30-day Notice
S090	2016-02-12	30-day Notice
S089	2016-02-12	30-day Notice
S088	2015-11-20	135 Review Track For 30-day Notice
S087	2015-11-19	30-day Notice
S086	2015-09-10	30-day Notice
S085	2015-09-03	30-day Notice
S084	2015-08-18	Special (immediate Track)
S083	2015-06-29	Normal 180 Day Track No User Fee
S082
S081	2015-04-29	30-day Notice
S080	2015-04-29	Special (immediate Track)
S079	2015-04-28	30-day Notice
S078	2015-04-13	30-day Notice
S077	2015-03-12	30-day Notice
S076	2015-01-13	Real-time Process
S075	2014-11-19	30-day Notice
S074	2014-09-22	30-day Notice
S073	2014-06-13	Normal 180 Day Track No User Fee
S072	2014-06-10	Normal 180 Day Track
S071	2014-05-05	Normal 180 Day Track No User Fee
S070	2014-04-30	30-day Notice
S069	2014-03-31	30-day Notice
S068	2014-03-28	30-day Notice
S067	2014-03-04	30-day Notice
S066	2014-02-24	30-day Notice
S065	2014-01-14	30-day Notice
S064	2013-11-21	30-day Notice
S063	2013-10-31	Special (immediate Track)
S062	2013-09-23	30-day Notice
S061	2013-09-19	30-day Notice
S060	2013-09-09	Special (immediate Track)
S059	2013-08-29	30-day Notice
S058	2013-03-25	135 Review Track For 30-day Notice
S057	2013-03-21	30-day Notice
S056	2013-03-04	30-day Notice
S055	2013-01-24	30-day Notice
S054	2012-12-26	30-day Notice
S053	2012-09-03	30-day Notice
S052	2012-04-27	30-day Notice
S051	2012-03-23	30-day Notice
S050	2011-11-07	30-day Notice
S049	2011-09-19	Real-time Process
S048	2011-06-21	Normal 180 Day Track No User Fee
S047	2011-06-09	Real-time Process
S046	2011-03-23	135 Review Track For 30-day Notice
S045	2011-02-28	Normal 180 Day Track No User Fee
S044	2010-10-07	135 Review Track For 30-day Notice
S043	2010-07-27	30-day Notice
S042	2010-05-27	30-day Notice
S041	2010-01-26	30-day Notice
S040	2009-06-03	Normal 180 Day Track No User Fee
S039	2009-04-06	Normal 180 Day Track
S038	2008-09-15	30-day Notice
S037	2007-03-12	Normal 180 Day Track No User Fee
S036	2006-09-21	Real-time Process
S035	2006-08-21	Real-time Process
S034	2006-05-16	30-day Notice
S033
S032
S031	2005-10-13	Normal 180 Day Track No User Fee
S030	2005-09-22	Normal 180 Day Track No User Fee
S029	2005-09-06	30-day Notice
S028	2005-07-18	Normal 180 Day Track
S027	2005-05-19	Real-time Process
S026	2005-01-24	Real-time Process
S025	2004-12-17	30-day Notice
S024	2004-05-26	Real-time Process
S023	2004-04-01	Real-time Process
S022	2003-12-08	30-day Notice
S021	2003-11-03	Normal 180 Day Track No User Fee
S020	2003-10-27	30-day Notice
S019	2003-05-05	Normal 180 Day Track No User Fee
S018	2002-08-28	Normal 180 Day Track
S017	2002-08-07	Real-time Process
S016	2001-11-23	30-day Notice
S015	2001-11-07	Normal 180 Day Track
S014	2001-03-26	30-day Notice
S013	1999-11-05	30-day Notice
S012	1999-03-23	Real-time Process
S011
S010	1998-10-06	Normal 180 Day Track
S009	1997-10-15	Normal 180 Day Track
S008	1997-08-15	Normal 180 Day Track
S007	1997-02-11	Normal 180 Day Track
S006	1996-10-24	Normal 180 Day Track
S005	1995-03-30	Special (immediate Track)
S004	1995-01-12	Normal 180 Day Track
S003	1994-12-05	Normal 180 Day Track
S002	1994-11-21	Normal 180 Day Track
S001	1994-11-17	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
08714729301578	P920047	000
08714729333319	P920047	000
08714729302889	P920047	000
08714729301585	P920047	000
08714729172079	P920047	000
08714729200031	P920047	000
08714729200024	P920047	000
08714729200017	P920047	000
08714729199977	P920047	000
08714729199960	P920047	000
08714729199953	P920047	000
08714729199946	P920047	000
08714729199939	P920047	000
08714729172093	P920047	000
08714729333326	P920047	000
08714729333333	P920047	000
08714729082439	P920047	000
08714729082811	P920047	000
08714729172048	P920047	000
08714729172055	P920047	000
08714729172062	P920047	000
08714729301707	P920047	000
08714729200055	P920047	000
08714729200048	P920047	000
08714729333388	P920047	000
08714729333371	P920047	000
08714729333364	P920047	000
08714729333357	P920047	000
08714729333340	P920047	000
08714729172086	P920047	000
08714729803669	P920047	039
08714729803591	P920047	039
08714729803607	P920047	039
08714729803614	P920047	039
08714729803621	P920047	039
08714729803645	P920047	039
08714729963974	P920047	104
08714729963950	P920047	104