Patient Cable

FDA Premarket Approval P820003 S139

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

To update the dose substantiation method for the 5846 disposable safety patient cables

• Device: Patient Cable
• Generic Name: Implantable Pulse Generator, Pacemaker (non-crt)
• Applicant: MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
• Date Received: 2022-01-18
• Decision Date: 2022-02-16
• PMA: P820003
• Supplement: S139
• Product Code: LWP
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 Coral Sea Street N.e. mounds View, MN 55112

Supplemental Filings

Supplement Number	Date	Supplement Type
P820003		Original Filing
S139	2022-01-18	30-day Notice
S138	2020-11-05	Normal 180 Day Track
S137	2016-11-14	30-day Notice
S136	2016-09-06	30-day Notice
S135	2015-07-02	Real-time Process
S134	2015-04-14	Real-time Process
S133	2015-03-27	30-day Notice
S132	2014-12-22	Normal 180 Day Track
S131	2014-08-27	30-day Notice
S130	2014-07-24	Real-time Process
S129	2014-07-02	Real-time Process
S128	2014-02-27	30-day Notice
S127	2014-02-27	30-day Notice
S126	2013-12-19	30-day Notice
S125	2013-10-24	30-day Notice
S124
S123	2013-07-10	Normal 180 Day Track No User Fee
S122	2013-07-10	30-day Notice
S121	2013-05-08	30-day Notice
S120	2013-04-18	Real-time Process
S119	2012-11-21	30-day Notice
S118	2012-11-06	30-day Notice
S117	2012-11-29	Normal 180 Day Track
S116	2012-04-04	Real-time Process
S115	2012-02-29	30-day Notice
S114	2011-11-25	Real-time Process
S113	2011-09-19	Real-time Process
S112	2011-08-18	30-day Notice
S111	2011-08-08	30-day Notice
S110	2011-07-18	30-day Notice
S109	2011-07-08	30-day Notice
S108	2011-06-28	30-day Notice
S107	2011-06-08	30-day Notice
S106	2011-05-13	30-day Notice
S105	2011-04-26	30-day Notice
S104	2011-01-04	Normal 180 Day Track
S103	2010-11-26	30-day Notice
S102	2010-11-12	30-day Notice
S101	2010-10-26	30-day Notice
S100	2010-09-28	135 Review Track For 30-day Notice
S099	2010-10-06	Real-time Process
S098	2010-07-19	30-day Notice
S097	2010-07-15	30-day Notice
S096	2010-07-15	30-day Notice
S095	2010-06-28	135 Review Track For 30-day Notice
S094
S093	2010-03-01	Real-time Process
S092	2009-06-17	Real-time Process
S091	2009-03-02	Normal 180 Day Track
S090	2009-02-13	30-day Notice
S089	2009-02-06	30-day Notice
S088	2009-01-12	30-day Notice
S087	2008-10-17	Real-time Process
S086	2008-09-23	135 Review Track For 30-day Notice
S085	2008-08-27	Normal 180 Day Track No User Fee
S084	2008-07-28	Normal 180 Day Track
S083
S082	2007-09-28	Normal 180 Day Track
S081	2007-07-19	Real-time Process
S080	2007-07-13	30-day Notice
S079	2007-03-09	Real-time Process
S078	2006-02-14	Real-time Process
S077	2005-12-22	Normal 180 Day Track No User Fee
S076	2005-12-09	Normal 180 Day Track
S075	2005-12-08	Real-time Process
S074	1999-07-19	Special (immediate Track)
S073	1996-06-10	Normal 180 Day Track
S072	1996-04-08	Normal 180 Day Track
S071	1995-08-10	Normal 180 Day Track
S070	1995-02-01	Normal 180 Day Track
S069	1994-11-03	Normal 180 Day Track
S068	1994-02-22	Normal 180 Day Track
S067	1993-06-21	Normal 180 Day Track
S066	1993-06-14	Normal 180 Day Track
S065	1993-04-06	Normal 180 Day Track
S064	1992-07-02	Normal 180 Day Track
S063	1992-03-12	Normal 180 Day Track
S062	1991-11-22	Normal 180 Day Track
S061	1991-11-13	Normal 180 Day Track
S060	1991-11-05	Normal 180 Day Track
S059	1991-07-29	Normal 180 Day Track
S058	1991-01-14	Normal 180 Day Track
S057	1991-01-04	Special (immediate Track)
S056	1990-11-08	Normal 180 Day Track
S055	1990-10-30	Normal 180 Day Track
S054	1990-08-24	Normal 180 Day Track
S053	1990-08-14	Normal 180 Day Track
S052	1990-07-24	Normal 180 Day Track
S051	1990-04-02	Normal 180 Day Track
S050	1990-03-13	Normal 180 Day Track
S049	1990-02-21	Normal 180 Day Track
S048	1990-01-29	Normal 180 Day Track
S047	1989-11-30	Normal 180 Day Track
S046	1989-09-29	Normal 180 Day Track
S045	1989-08-17	Normal 180 Day Track
S044	1989-08-03	Normal 180 Day Track
S043	1989-07-20	Normal 180 Day Track
S042	1989-03-22	Normal 180 Day Track
S041	1989-01-26	Normal 180 Day Track
S040	1988-11-17	Normal 180 Day Track
S039	1988-11-08	Normal 180 Day Track
S038	1988-10-14	Normal 180 Day Track
S037	1988-02-17	Normal 180 Day Track
S036	1988-02-11	Normal 180 Day Track
S035	1988-01-15	Normal 180 Day Track
S034	1987-10-03	Normal 180 Day Track
S033	1987-07-22	Normal 180 Day Track
S032	1987-06-29	Normal 180 Day Track
S031	1987-02-06	Normal 180 Day Track
S030	1986-11-17	Normal 180 Day Track
S029	1986-06-30	Normal 180 Day Track
S028	1986-05-28	Normal 180 Day Track
S027	1986-03-19
S026	1986-02-03
S025	1985-12-24
S024	1985-11-08
S023	1985-10-22
S022	1985-09-20
S021	1985-06-25
S020
S019	1985-03-14
S018	1985-02-28
S017	1985-02-22
S016	1985-01-04
S015	1984-12-13
S014
S013	1984-10-26
S012	1984-10-02
S011	1984-05-29
S010	1984-02-08
S009	1983-12-06
S008	1983-11-10
S007	1983-05-31
S006	1983-05-10
S005	1983-02-14
S004	1983-02-01
S003	1983-01-03
S002	1982-11-17
S001

NIH GUDID Devices

Device ID	PMA	Supp
20763000181110	P820003	000
00681490399708	P820003	000
10721902187077	P820003	000
10721902187060	P820003	000
10721902187053	P820003	000
10721902187046	P820003	000
20613994524274	P820003	000
20763000181134	P820003	000
20613994300083	P820003	072
00613994521781	P820003	072
00681490132367	P820003	077
00613994426550	P820003	077
00681490132374	P820003	077
00681490132428	P820003	077
00681490132435	P820003	077
20643169431670	P820003	118
20643169431618	P820003	118
20643169431656	P820003	118
20643169307395	P820003	118
20643169307364	P820003	118
20643169307388	P820003	118
20643169307371	P820003	118
20643169431632	P820003	118
00643169703254	P820003	130
00643169703261	P820003	130
00643169703285	P820003	130
00643169703346	P820003	130
00643169703278	P820003	130
00763000181208	P820003	138