MEDTRONIC{R} CAPSURE{TM} MODEL 5052/5525

Permanent Pacemaker Electrode

FDA Premarket Approval P850089 S008

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

• Device: MEDTRONIC{R} CAPSURE{TM} MODEL 5052/5525
• Classification Name: Permanent Pacemaker Electrode
• Generic Name: Permanent Pacemaker Electrode
• Applicant: MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
• Date Received: 1988-10-21
• Decision Date: 1989-02-03
• PMA: P850089
• Supplement: S008
• Product Code: DTB
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Location 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
P850089		Original Filing
S163	2022-11-16	30-day Notice
S162	2022-05-20	30-day Notice
S161	2022-04-14	30-day Notice
S160	2022-01-13	30-day Notice
S159	2021-11-18	30-day Notice
S158
S157	2021-08-13	30-day Notice
S156	2021-08-09	30-day Notice
S155	2021-06-15	30-day Notice
S154	2021-02-05	30-day Notice
S153	2021-01-12	30-day Notice
S152	2020-12-01	30-day Notice
S151	2020-11-24	30-day Notice
S150	2020-10-23	30-day Notice
S149	2020-07-09	30-day Notice
S148	2020-06-26	30-day Notice
S147	2020-03-23	Real-time Process
S146	2020-02-20	30-day Notice
S145	2019-11-18	30-day Notice
S144	2019-09-16	30-day Notice
S143	2019-07-01	30-day Notice
S142	2019-06-20	30-day Notice
S141	2019-06-10	30-day Notice
S140	2019-02-28	30-day Notice
S139	2018-11-21	30-day Notice
S138	2018-10-23	30-day Notice
S137	2018-10-18	30-day Notice
S136	2018-09-26	30-day Notice
S135	2018-06-20	30-day Notice
S134	2018-06-01	30-day Notice
S133	2018-05-15	30-day Notice
S132	2018-04-09	30-day Notice
S131	2018-03-28	30-day Notice
S130	2018-02-22	30-day Notice
S129	2017-11-20	30-day Notice
S128	2017-10-20	30-day Notice
S127	2017-08-07	30-day Notice
S126	2017-06-28	30-day Notice
S125	2017-06-23	30-day Notice
S124	2017-06-07	30-day Notice
S123	2017-01-17	30-day Notice
S122	2016-11-28	30-day Notice
S121	2016-11-14	30-day Notice
S120	2016-10-05	30-day Notice
S119	2016-09-02	30-day Notice
S118	2016-06-24	30-day Notice
S117	2016-03-17	30-day Notice
S116	2015-12-28	30-day Notice
S115	2015-12-22	30-day Notice
S114	2015-04-17	30-day Notice
S113	2015-02-09	30-day Notice
S112	2014-09-29	30-day Notice
S111	2014-08-27	30-day Notice
S110	2014-08-08	30-day Notice
S109	2014-07-24	30-day Notice
S108	2014-07-14	30-day Notice
S107	2014-02-27	30-day Notice
S106	2014-01-29	30-day Notice
S105	2013-12-24	30-day Notice
S104	2013-12-19	30-day Notice
S103	2013-10-30	30-day Notice
S102	2013-10-24	30-day Notice
S101	2013-09-30	30-day Notice
S100	2013-09-17	30-day Notice
S099	2013-05-21	30-day Notice
S098	2013-05-17	Real-time Process
S097	2013-04-30	30-day Notice
S096
S095	2013-04-10	Normal 180 Day Track No User Fee
S094	2013-03-22	30-day Notice
S093	2013-03-20	30-day Notice
S092	2012-12-10	30-day Notice
S091	2012-11-21	30-day Notice
S090	2012-09-28	30-day Notice
S089	2012-08-03	30-day Notice
S088	2012-06-11	30-day Notice
S087	2012-02-29	30-day Notice
S086	2011-11-25	30-day Notice
S085	2011-11-21	Normal 180 Day Track
S084	2011-10-24	135 Review Track For 30-day Notice
S083	2011-07-18	30-day Notice
S082	2011-07-08	30-day Notice
S081	2011-06-28	30-day Notice
S080	2011-06-27	30-day Notice
S079	2011-06-08	30-day Notice
S078	2011-06-08	135 Review Track For 30-day Notice
S077	2011-05-13	30-day Notice
S076	2011-04-26	30-day Notice
S075	2011-03-22	135 Review Track For 30-day Notice
S074	2011-03-18	135 Review Track For 30-day Notice
S073	2011-02-28	30-day Notice
S072	2010-11-12	30-day Notice
S071	2010-10-26	30-day Notice
S070	2010-09-29	30-day Notice
S069	2010-07-15	30-day Notice
S068	2010-07-15	30-day Notice
S067	2010-07-15	30-day Notice
S066	2010-06-28	135 Review Track For 30-day Notice
S065	2010-03-29	30-day Notice
S064	2010-01-19	30-day Notice
S063	2010-01-15	Real-time Process
S062	2009-10-08	Real-time Process
S061	2009-02-05	30-day Notice
S060	2008-12-11	30-day Notice
S059
S058	2008-03-24	30-day Notice
S057	2008-03-10	135 Review Track For 30-day Notice
S056	2007-06-27	30-day Notice
S055	2007-05-18	30-day Notice
S054	2006-05-10	135 Review Track For 30-day Notice
S053	2004-03-01	135 Review Track For 30-day Notice
S052	2003-03-04	30-day Notice
S051	2002-12-24	Real-time Process
S050	2001-11-14	Real-time Process
S049	2001-11-05	Special (immediate Track)
S048
S047	2001-07-17	30-day Notice
S046	2001-05-21	Real-time Process
S045	2000-12-07	Real-time Process
S044	2000-01-11	30-day Notice
S043	2000-01-05	30-day Notice
S042	1999-07-09	Real-time Process
S041	1999-05-03	Special (immediate Track)
S040	1998-10-01	Real-time Process
S039	1998-04-20
S038	1997-11-03	Normal 180 Day Track
S037	1997-10-10	Real-time Process
S036	1996-11-20	Normal 180 Day Track
S035	1996-05-08	Normal 180 Day Track
S034	1996-05-02	Normal 180 Day Track
S033	1995-04-06	Normal 180 Day Track
S032	1995-01-30	Normal 180 Day Track
S031	1994-09-08	Normal 180 Day Track
S030	1994-08-08	Normal 180 Day Track
S029	1994-06-01	Normal 180 Day Track
S028	1993-08-06	Normal 180 Day Track
S027	1993-03-29	Normal 180 Day Track
S026	1992-12-24	Normal 180 Day Track
S025
S024	1992-06-15	Normal 180 Day Track
S023	1992-03-30	Normal 180 Day Track
S022
S021
S020	1992-01-27	Special (immediate Track)
S019
S018	1991-10-03	Normal 180 Day Track
S017	1991-07-29	Normal 180 Day Track
S016	1991-05-16	Normal 180 Day Track
S015	1990-08-20	Normal 180 Day Track
S014	1990-05-15	Normal 180 Day Track
S013	1990-04-18	Normal 180 Day Track
S012	1990-03-12	Normal 180 Day Track
S011	1989-03-02	Normal 180 Day Track
S010	1989-02-23	Normal 180 Day Track
S009	1988-01-03	Normal 180 Day Track
S008	1988-10-21	Normal 180 Day Track
S007	1988-03-08	Normal 180 Day Track
S006	1988-02-25	Normal 180 Day Track
S005	1987-07-08	Normal 180 Day Track
S004	1987-06-23	Normal 180 Day Track
S003	1986-09-25	Normal 180 Day Track
S002	1986-09-11	Normal 180 Day Track
S001	1986-08-28	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
00613994560438	P850089	038
00681490141352	P850089	038
00681490135733	P850089	038
00681490135047	P850089	038
00681490125109	P850089	038
00681490125048	P850089	038
00681490123167	P850089	038
00763000059187	P850089	038
00763000059170	P850089	038
00763000059163	P850089	038
00763000059149	P850089	038
00763000059132	P850089	038
00763000569112	P850089	038
00763000569105	P850089	038
00763000569099	P850089	038
00763000569075	P850089	038
00613994560421	P850089	038
00613994560414	P850089	038
00613994560391	P850089	038
00613994560384	P850089	038
00613994250223	P850089	040
00613994250230	P850089	040
00681490135108	P850089	045
00681490135696	P850089	045
00681490123228	P850089	045
00643169638792	P850089	110
00643169638785	P850089	110
00643169638747	P850089	110
00643169590700	P850089	110
00643169638730	P850089	110
00643169590694	P850089	110
00643169590687	P850089	110
00643169590724	P850089	110
00643169590663	P850089	110
00643169590731	P850089	110
00643169590748	P850089	110
00643169590755	P850089	110
00643169590762	P850089	110
00643169590670	P850089	110