VENTAK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM FAMILY

Implantable Cardioverter Defibrillator (non-crt)

FDA Premarket Approval P830060 S074

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

Replace the traceability and tracking system.

• Device: VENTAK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM FAMILY
• Classification Name: Implantable Cardioverter Defibrillator (non-crt)
• Generic Name: Implantable Cardioverter Defibrillator (non-crt)
• Applicant: BOSTON SCIENTIFIC
• Date Received: 2012-11-08
• Decision Date: 2012-12-05
• PMA: P830060
• Supplement: S074
• Product Code: LWS
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: BOSTON SCIENTIFIC 4100 Hamline Avenue North st. Paul, MN 55112

Supplemental Filings

Supplement Number	Date	Supplement Type
P830060		Original Filing
S088	2022-11-01	30-day Notice
S087	2021-09-30	30-day Notice
S086	2021-04-30	30-day Notice
S085	2021-03-08	30-day Notice
S084	2021-02-24	Normal 180 Day Track No User Fee
S083	2019-03-13	30-day Notice
S082	2018-03-26	30-day Notice
S081	2016-05-27	30-day Notice
S080	2014-06-30	30-day Notice
S079	2014-04-22	30-day Notice
S078	2014-03-04	Real-time Process
S077	2014-02-21	Real-time Process
S076	2013-08-29	30-day Notice
S075	2013-05-16	Real-time Process
S074	2012-11-08	30-day Notice
S073	2012-10-10	30-day Notice
S072	2012-07-26	Real-time Process
S071
S070	2012-03-26	30-day Notice
S069	2011-05-25	30-day Notice
S068	2011-04-01	30-day Notice
S067	2011-03-28	Real-time Process
S066
S065	2009-12-18	30-day Notice
S064	2009-12-16	30-day Notice
S063
S062	2009-02-24	Normal 180 Day Track
S061
S060	2006-04-13	30-day Notice
S059	2006-04-13	30-day Notice
S058	2005-05-27	Special (immediate Track)
S057	2004-12-03	30-day Notice
S056	2004-10-21	30-day Notice
S055	2004-06-14	30-day Notice
S054	2004-04-14	30-day Notice
S053	2004-01-13	30-day Notice
S052	2003-10-30	Special (immediate Track)
S051	2002-11-13	30-day Notice
S050
S049	2000-08-21	Normal 180 Day Track
S048	2000-04-27	Real-time Process
S047	2000-01-11	Real-time Process
S046	1999-12-16	Normal 180 Day Track
S045	1999-08-25	Normal 180 Day Track
S044	1998-11-20	Real-time Process
S043	1998-10-13	Real-time Process
S042	1996-10-16	Normal 180 Day Track
S041	1995-12-21	Normal 180 Day Track
S040	1995-02-10	Normal 180 Day Track
S039	1995-05-01	Normal 180 Day Track
S038	1995-04-06	Normal 180 Day Track
S037	1994-12-23	Normal 180 Day Track
S036	1994-12-14	Normal 180 Day Track
S035	1994-04-20	Normal 180 Day Track
S034	1993-10-19	Normal 180 Day Track
S033	1993-04-15	Normal 180 Day Track
S032	1992-08-26	Normal 180 Day Track
S031
S030	1992-04-29	Normal 180 Day Track
S029	1991-11-22	Normal 180 Day Track
S028	1991-11-07	Normal 180 Day Track
S027	1991-09-23	Normal 180 Day Track
S026	1991-07-05	Normal 180 Day Track
S025	1991-05-15	Normal 180 Day Track
S024	1990-11-13	Normal 180 Day Track
S023	1990-09-27	Normal 180 Day Track
S022	1990-09-26	Normal 180 Day Track
S021	1990-08-15	Normal 180 Day Track
S020	1990-07-23	Normal 180 Day Track
S019	1990-05-04	Normal 180 Day Track
S018	1990-03-07	Normal 180 Day Track
S017
S016	1990-03-01	Normal 180 Day Track
S015	1990-02-15	Normal 180 Day Track
S014	1990-02-15	Normal 180 Day Track
S013	1989-11-20	Normal 180 Day Track
S012	1989-10-31	Normal 180 Day Track
S011	1989-10-17	Normal 180 Day Track
S010	1989-10-12	Normal 180 Day Track
S009
S008	1989-06-13	Normal 180 Day Track
S007	1988-08-15	Normal 180 Day Track
S006	1988-03-08	Normal 180 Day Track
S005	1987-09-22	Normal 180 Day Track
S004	1986-09-16	Normal 180 Day Track
S003	1986-08-06	Special (immediate Track)
S002	1986-02-03
S001	1985-12-03

NIH GUDID Devices

Device ID	PMA	Supp
00802526489303	P830060	000
00802526067310	P830060	000
00802526489600	P830060	000
00802526489563	P830060	000
00802526489280	P830060	000
00802526489594	P830060	023
00802526489587	P830060	023
00802526489730	P830060	045
00802526489723	P830060	045
00802526067518	P830060	067
00802526064395	P830060	077
00802526617300	P830060	084