MEDTRONIC ELITE(TM) MODELS 7074,7075,7076,& 7077

Implantable Pacemaker Pulse-generator

FDA Premarket Approval P890003 S003

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 ELITE(TM) MODELS 7074,7075,7076,& 7077
• Classification Name: Implantable Pacemaker Pulse-generator
• Generic Name: Implantable Pacemaker Pulse-generator
• Applicant: Medtronic, Inc.
• Date Received: 1990-08-10
• Decision Date: 1991-04-24
• PMA: P890003
• Supplement: S003
• Product Code: DXY
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: Medtronic, Inc. 8200 Coral Sea Street N.e. mounds View, MN 55112

Supplemental Filings

Supplement Number	Date	Supplement Type
P890003		Original Filing
S458	2022-11-16	30-day Notice
S457
S456	2022-07-25	Real-time Process
S455
S454	2022-05-20	30-day Notice
S453	2022-04-20	30-day Notice
S452	2022-04-14	30-day Notice
S451	2022-01-13	30-day Notice
S450	2021-11-18	30-day Notice
S449
S448	2021-08-23	Real-time Process
S447	2021-08-09	30-day Notice
S446	2021-06-15	30-day Notice
S445
S444	2021-03-01	Real-time Process
S443	2021-02-25	Real-time Process
S442	2021-02-05	30-day Notice
S441	2020-12-01	30-day Notice
S440	2020-11-24	30-day Notice
S439
S438
S437
S436	2020-10-23	30-day Notice
S435	2020-09-17	30-day Notice
S434
S433	2020-07-09	30-day Notice
S432	2020-06-26	30-day Notice
S431
S430	2020-05-29	Real-time Process
S429	2020-03-23	Real-time Process
S428	2020-02-28	Real-time Process
S427	2020-02-21	Real-time Process
S426	2020-02-20	30-day Notice
S425	2019-12-23	Real-time Process
S424	2019-11-25	30-day Notice
S423	2019-11-25	30-day Notice
S422	2019-11-18	30-day Notice
S421
S420	2019-10-21	30-day Notice
S419	2019-09-16	30-day Notice
S418	2019-07-11	Real-time Process
S417	2019-07-01	30-day Notice
S416
S415	2019-06-21	30-day Notice
S414	2019-06-20	30-day Notice
S413	2019-06-10	30-day Notice
S412
S411
S410	2019-04-23	30-day Notice
S409	2019-03-28	30-day Notice
S408	2019-03-25	Real-time Process
S407
S406	2019-03-18	Real-time Process
S405	2019-02-28	30-day Notice
S404
S403	2019-01-30	Normal 180 Day Track No User Fee
S402	2018-11-21	30-day Notice
S401	2018-11-16	Real-time Process
S400	2018-10-23	30-day Notice
S399	2018-10-18	30-day Notice
S398	2018-10-03	Real-time Process
S397	2018-09-26	30-day Notice
S396	2018-08-22	Real-time Process
S395	2018-08-22	Real-time Process
S394	2018-07-06	Real-time Process
S393	2018-06-20	30-day Notice
S392	2018-06-01	30-day Notice
S391	2018-05-15	30-day Notice
S390	2018-04-17	Real-time Process
S389	2018-04-09	30-day Notice
S388	2018-03-28	30-day Notice
S387	2018-02-22	30-day Notice
S386	2018-02-12	Normal 180 Day Track
S385	2018-02-01	Real-time Process
S384	2017-12-14	Real-time Process
S383	2017-11-20	30-day Notice
S382	2017-10-20	30-day Notice
S381	2017-09-05	Real-time Process
S380	2017-09-01	Real-time Process
S379	2017-08-07	30-day Notice
S378	2017-07-21	Normal 180 Day Track
S377	2017-06-30	Real-time Process
S376	2017-06-28	30-day Notice
S375	2017-06-23	30-day Notice
S374	2017-05-18	Normal 180 Day Track
S373	2017-04-06	Real-time Process
S372	2016-12-15	Normal 180 Day Track
S371	2016-12-05	Real-time Process
S370	2016-11-28	30-day Notice
S369	2016-11-23	Real-time Process
S368	2016-11-16	Normal 180 Day Track
S367	2016-11-14	30-day Notice
S366	2016-10-05	30-day Notice
S365	2016-09-08	Real-time Process
S364	2016-09-06	30-day Notice
S363	2016-09-02	30-day Notice
S362	2016-07-15	30-day Notice
S361	2016-07-13	Real-time Process
S360	2016-06-27	Real-time Process
S359	2016-06-24	30-day Notice
S358	2016-06-24	Real-time Process
S357	2016-05-06	Real-time Process
S356	2016-05-03	Normal 180 Day Track
S355	2016-04-28	Real-time Process
S354	2016-04-15	Normal 180 Day Track
S353	2016-04-14	Real-time Process
S352	2016-03-18	Real-time Process
S351	2016-03-18	Real-time Process
S350	2016-03-17	Real-time Process
S349
S348	2015-12-28	30-day Notice
S347	2015-12-22	30-day Notice
S346	2015-12-18	Real-time Process
S345	2015-12-01	Normal 180 Day Track
S344	2015-11-16	Normal 180 Day Track
S343	2015-10-22	Real-time Process
S342	2015-10-22	Real-time Process
S341	2015-10-16	Real-time Process
S340	2015-10-14	30-day Notice
S339	2015-09-30	Normal 180 Day Track
S338	2015-09-24	Normal 180 Day Track
S337	2015-09-10	30-day Notice
S336	2015-08-28	Real-time Process
S335
S334	2015-07-31	Real-time Process
S333	2015-07-02	Real-time Process
S332
S331	2015-04-17	30-day Notice
S330	2015-04-14	Real-time Process
S329	2015-03-16	Normal 180 Day Track
S328	2015-03-06	Real-time Process
S327	2015-02-09	30-day Notice
S326	2014-12-22	Normal 180 Day Track
S325	2014-11-19	30-day Notice
S324	2014-10-14	30-day Notice
S323	2014-10-02	30-day Notice
S322	2014-09-29	30-day Notice
S321	2014-08-27	30-day Notice
S320	2014-08-27	Real-time Process
S319	2014-08-19	Real-time Process
S318	2014-08-15	Real-time Process
S317	2014-08-08	30-day Notice
S316	2014-08-06	30-day Notice
S315	2014-07-24	30-day Notice
S314	2014-07-24	Real-time Process
S313	2014-07-18	Normal 180 Day Track
S312	2014-07-14	30-day Notice
S311	2014-07-02	Real-time Process
S310	2014-06-06	30-day Notice
S309	2014-04-11	Normal 180 Day Track
S308	2014-04-01	30-day Notice
S307	2014-03-28	Real-time Process
S306	2014-03-28	Real-time Process
S305	2014-03-18	Real-time Process
S304	2014-03-05	Real-time Process
S303	2014-02-27	30-day Notice
S302	2014-01-29	30-day Notice
S301	2013-12-24	30-day Notice
S300	2013-12-23	30-day Notice
S299	2013-12-19	Real-time Process
S298	2013-12-19	30-day Notice
S297	2013-12-18	Normal 180 Day Track
S296	2013-12-17	30-day Notice
S295	2013-12-16	Normal 180 Day Track
S294	2013-12-13	30-day Notice
S293	2013-11-27	30-day Notice
S292	2013-11-12	Normal 180 Day Track No User Fee
S291	2013-10-30	30-day Notice
S290	2013-10-24	Real-time Process
S289	2013-10-24	30-day Notice
S288	2013-09-30	30-day Notice
S287	2013-09-17	30-day Notice
S286	2013-09-17	30-day Notice
S285	2013-08-23	Normal 180 Day Track
S284	2013-08-12	Real-time Process
S283	2013-08-06	Real-time Process
S282	2013-07-26	30-day Notice
S281	2013-07-10	Normal 180 Day Track No User Fee
S280	2013-07-08	Normal 180 Day Track
S279	2013-05-30	30-day Notice
S278	2013-05-17	Real-time Process
S277	2013-05-13	Real-time Process
S276	2013-05-10	30-day Notice
S275	2013-04-30	30-day Notice
S274
S273	2013-04-18	Real-time Process
S272	2013-04-10	Normal 180 Day Track No User Fee
S271	2013-03-22	30-day Notice
S270
S269	2013-02-26	Normal 180 Day Track
S268	2013-02-21	Normal 180 Day Track No User Fee
S267	2012-12-10	30-day Notice
S266	2012-11-21	30-day Notice
S265	2012-11-29	Normal 180 Day Track
S264	2012-10-19	30-day Notice
S263	2012-10-11	Real-time Process
S262	2012-09-26	30-day Notice
S261	2012-09-28	30-day Notice
S260	2012-09-13	Normal 180 Day Track
S259	2012-09-04	Normal 180 Day Track
S258	2012-08-24	Real-time Process
S257	2012-08-21	30-day Notice
S256	2012-08-13	30-day Notice
S255	2012-08-03	30-day Notice
S254	2012-07-17	Normal 180 Day Track
S253	2012-07-05	Normal 180 Day Track
S252	2012-06-29	Normal 180 Day Track
S251	2012-06-14	Normal 180 Day Track
S250	2012-06-11	30-day Notice
S249	2012-04-04	Real-time Process
S248	2012-03-07	30-day Notice
S247	2012-03-07	Normal 180 Day Track
S246	2012-02-29	30-day Notice
S245	2012-02-27	Real-time Process
S244
S243	2011-12-20	30-day Notice
S242	2011-11-25	Real-time Process
S241	2011-11-25	30-day Notice
S240	2011-11-21	Normal 180 Day Track
S239	2011-11-09	30-day Notice
S238	2011-11-04	Real-time Process
S237	2011-10-24	135 Review Track For 30-day Notice
S236	2011-09-22	30-day Notice
S235	2011-09-19	Real-time Process
S234	2011-07-18	30-day Notice
S233	2011-07-08	30-day Notice
S232	2011-07-06	30-day Notice
S231	2011-06-28	30-day Notice
S230	2011-06-08	30-day Notice
S229	2011-06-08	135 Review Track For 30-day Notice
S228	2011-05-25	Real-time Process
S227
S226	2011-05-19	Real-time Process
S225	2011-05-13	30-day Notice
S224	2011-05-10	30-day Notice
S223	2011-05-09	30-day Notice
S222
S221	2011-04-26	30-day Notice
S220	2011-03-29	Real-time Process
S219	2011-03-22	135 Review Track For 30-day Notice
S218	2011-03-18	135 Review Track For 30-day Notice
S217	2011-03-07	30-day Notice
S216	2011-02-28	30-day Notice
S215	2011-02-18	30-day Notice
S214	2011-02-09	Normal 180 Day Track
S213
S212	2011-01-25	30-day Notice
S211	2011-01-04	Normal 180 Day Track
S210	2010-12-23	Real-time Process
S209	2010-12-22	Normal 180 Day Track
S208	2010-11-23	30-day Notice
S207	2010-11-12	30-day Notice
S206	2010-10-26	30-day Notice
S205	2010-10-22	30-day Notice
S204	2010-10-12	30-day Notice
S203	2010-09-29	30-day Notice
S202
S201
S200	2010-09-09	30-day Notice
S199
S198	2010-07-15	30-day Notice
S197	2010-07-15	30-day Notice
S196	2010-07-15	30-day Notice
S195	2010-07-06	Real-time Process
S194	2010-06-28	135 Review Track For 30-day Notice
S193	2010-05-20	Real-time Process
S192	2010-05-17	Normal 180 Day Track
S191	2010-04-22	Normal 180 Day Track
S190	2010-04-15	30-day Notice
S189	2010-03-31	Normal 180 Day Track
S188	2010-03-31	Real-time Process
S187	2010-03-29	30-day Notice
S186	2010-03-01	Real-time Process
S185	2010-01-21	30-day Notice
S184	2010-01-19	30-day Notice
S183	2010-01-15	Real-time Process
S182	2010-01-13	30-day Notice
S181	2009-12-23	Normal 180 Day Track
S180	2009-12-18	30-day Notice
S179	2009-12-04	Normal 180 Day Track
S178	2009-11-17	Real-time Process
S177	2009-10-22	Normal 180 Day Track
S176	2009-10-09	30-day Notice
S175	2009-10-08	Real-time Process
S174	2009-09-08	30-day Notice
S173	2009-07-28	Real-time Process
S172	2009-06-17	Real-time Process
S171	2009-04-10	30-day Notice
S170
S169	2009-03-06	Normal 180 Day Track
S168	2009-03-02	Normal 180 Day Track
S167	2009-02-26	30-day Notice
S166	2009-02-23	Real-time Process
S165	2009-02-18	135 Review Track For 30-day Notice
S164	2009-02-09	135 Review Track For 30-day Notice
S163	2009-02-05	30-day Notice
S162	2008-12-22	Normal 180 Day Track No User Fee
S161	2008-12-15	30-day Notice
S160	2008-12-11	30-day Notice
S159	2008-12-11	30-day Notice
S158	2008-11-20	30-day Notice
S157
S156	2008-11-12	30-day Notice
S155	2008-11-07	Real-time Process
S154	2008-11-04	Normal 180 Day Track
S153	2008-11-03	30-day Notice
S152	2008-10-21	30-day Notice
S151	2008-10-17	Real-time Process
S150	2008-09-26	Real-time Process
S149
S148	2008-08-28	Real-time Process
S147
S146	2008-07-30	135 Review Track For 30-day Notice
S145	2008-07-28	Normal 180 Day Track
S144	2008-07-25	135 Review Track For 30-day Notice
S143	2008-06-27	135 Review Track For 30-day Notice
S142	2008-06-17	30-day Notice
S141	2008-06-13	Real-time Process
S140	2008-06-10	30-day Notice
S139	2008-04-14	30-day Notice
S138	2008-03-24	30-day Notice
S137	2008-03-21	30-day Notice
S136	2008-01-25	30-day Notice
S135
S134	2008-01-25	30-day Notice
S133	2007-12-07	30-day Notice
S132	2007-11-19	30-day Notice
S131	2007-10-31	Normal 180 Day Track
S130	2007-10-11	30-day Notice
S129	2007-09-28	Normal 180 Day Track
S128	2007-10-09	30-day Notice
S127	2007-09-24	Normal 180 Day Track No User Fee
S126	2007-08-23	Special (immediate Track)
S125	2007-08-14	Real-time Process
S124	2007-07-26	Real-time Process
S123	2007-06-15	Real-time Process
S122	2007-06-11	Real-time Process
S121	2007-05-18	30-day Notice
S120	2007-05-14	Real-time Process
S119	2007-05-10	Real-time Process
S118	2007-05-21	Real-time Process
S117	2007-03-09	Real-time Process
S116	2007-02-28	Real-time Process
S115	2006-12-20	Real-time Process
S114	2006-12-01	Normal 180 Day Track No User Fee
S113	2006-11-20	30-day Notice
S112	2006-10-31	Real-time Process
S111	2006-10-30	Normal 180 Day Track No User Fee
S110	2006-10-13	Real-time Process
S109	2006-10-03	Special (immediate Track)
S108	2006-08-21	Normal 180 Day Track No User Fee
S107	2006-07-21	Real-time Process
S106	2006-07-13	Real-time Process
S105	2006-06-19	Real-time Process
S104	2006-05-10	135 Review Track For 30-day Notice
S103	2006-04-10	Real-time Process
S102	2006-04-06	Real-time Process
S101	2006-02-21	Real-time Process
S100	2006-02-14	Real-time Process
S099	2006-02-01	Special (immediate Track)
S098	2005-12-22	Normal 180 Day Track No User Fee
S097	2005-12-09	Normal 180 Day Track
S096	2005-11-07	Real-time Process
S095	2005-10-19	Real-time Process
S094
S093	2005-10-07	Real-time Process
S092	2005-10-06	135 Review Track For 30-day Notice
S091	2005-10-05	Real-time Process
S090
S089	2005-09-16	Real-time Process
S088	2005-08-23	Real-time Process
S087	2005-06-06	Real-time Process
S086	2005-05-06	Normal 180 Day Track
S085	2005-05-05	Real-time Process
S084	2005-04-15	Normal 180 Day Track No User Fee
S083
S082	2005-01-31	Normal 180 Day Track
S081	2005-01-21	Real-time Process
S080	2004-12-06	Real-time Process
S079	2004-11-01	Normal 180 Day Track No User Fee
S078	2004-10-05	Real-time Process
S077	2004-09-20	Normal 180 Day Track
S076	2004-08-27	30-day Notice
S075	2004-08-23	Real-time Process
S074	2004-02-12	Real-time Process
S073	2003-11-28	Real-time Process
S072	2003-08-22	Normal 180 Day Track No User Fee
S071	2003-08-19	Real-time Process
S070
S069	2002-05-13	Real-time Process
S068	2001-10-15	Normal 180 Day Track
S067	2001-12-13	30-day Notice
S066	2001-11-13	Special (immediate Track)
S065	2001-09-14	Normal 180 Day Track
S064	2001-07-17	30-day Notice
S063	2001-04-11	Normal 180 Day Track
S062	2001-04-11	Real-time Process
S061	2000-08-02	Real-time Process
S060	2000-06-30	Real-time Process
S059
S058	1999-12-13	Real-time Process
S057	1998-06-12	30-day Notice
S056	1998-04-28	Real-time Process
S055	1998-04-20
S054	1998-04-03	Normal 180 Day Track
S053
S052	1997-08-18	Normal 180 Day Track
S051	1997-06-24	Normal 180 Day Track
S050	1997-05-05	Normal 180 Day Track
S049
S048	1996-10-22	Normal 180 Day Track
S047	1996-10-01	Normal 180 Day Track
S046	1996-05-20	Normal 180 Day Track
S045	1996-05-02	Normal 180 Day Track
S044	1996-03-14	Normal 180 Day Track
S043	1996-02-09	Normal 180 Day Track
S042	1995-08-16	Normal 180 Day Track
S041	1995-08-10	Normal 180 Day Track
S040	1995-04-26	Normal 180 Day Track
S039	1995-04-20	Normal 180 Day Track
S038	1995-04-11	Special (immediate Track)
S037	1995-04-06	Normal 180 Day Track
S036	1995-02-16	Normal 180 Day Track
S035	1994-12-22	Normal 180 Day Track
S034
S033	1994-10-11	Normal 180 Day Track
S032	1994-06-15	Normal 180 Day Track
S031	1994-05-23	Normal 180 Day Track
S030	1994-03-18	Normal 180 Day Track
S029	1994-03-17	Normal 180 Day Track
S028	1994-02-16	Normal 180 Day Track
S027	1994-02-10	Normal 180 Day Track
S026
S025	1994-01-04	Normal 180 Day Track
S024	1993-12-29	Normal 180 Day Track
S023	1993-06-21	Normal 180 Day Track
S022	1993-06-14	Normal 180 Day Track
S021	1993-04-07	Normal 180 Day Track
S020	1992-12-08	Normal 180 Day Track
S019	1992-07-20	Normal 180 Day Track
S018	1992-07-13	Normal 180 Day Track
S017	1992-07-10	Normal 180 Day Track
S016	1992-03-26	Normal 180 Day Track
S015	1992-03-26	Normal 180 Day Track
S014	1992-03-26	Normal 180 Day Track
S013	1991-11-22	Normal 180 Day Track
S012	1991-10-16	Normal 180 Day Track
S011	1991-09-30	Normal 180 Day Track
S010	1991-08-09	Normal 180 Day Track
S009	1991-08-02	Normal 180 Day Track
S008	1991-07-23	Normal 180 Day Track
S007	1991-05-10	Normal 180 Day Track
S006	1991-01-14	Normal 180 Day Track
S005	1990-10-30	Normal 180 Day Track
S004	1990-08-24	Normal 180 Day Track
S003	1990-08-10	Normal 180 Day Track
S002	1989-11-30	Normal 180 Day Track
S001	1989-09-29	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
00721902438400	P890003	000
00681490501880	P890003	027
00681490207256	P890003	046
00613994250148	P890003	050
00885074201566	P890003	050
00613994250155	P890003	050
00885074201573	P890003	050
00681490122832	P890003	050
00681490122733	P890003	050
00681490122931	P890003	050
00721902046940	P890003	063
00721902307294	P890003	065
00721902290138	P890003	065
00721902824692	P890003	065
00721902290121	P890003	065
00721902283819	P890003	065
00721902307300	P890003	065
00721902546655	P890003	065
00721902710322	P890003	065
00721902710346	P890003	065
00721902710353	P890003	065
00681490132558	P890003	065
10681490142653	P890003	065
00643169431850	P890003	065
00721902283802	P890003	065
00721902256011	P890003	065
20763000842530	P890003	065
00763000307660	P890003	065
00613994521750	P890003	065
00613994435125	P890003	065
00613994175397	P890003	065
00613994362896	P890003	065
00613994175403	P890003	065
00613994127631	P890003	065
00721902307317	P890003	065
00885074301440	P890003	080
00613994119995	P890003	097
00721902309588	P890003	098
00721902309564	P890003	098
00613994910387	P890003	110
00643169312913	P890003	110
00643169102101	P890003	110
00613994381071	P890003	127
00613994434937	P890003	145
00613994581570	P890003	151
00613994501011	P890003	162
00763000059477	P890003	162
00613994581594	P890003	172
00643169192058	P890003	228
00613994952431	P890003	228
00643169341074	P890003	228
00613994952400	P890003	228
00643169102095	P890003	238
00643169312098	P890003	253
00643169191815	P890003	253
00613994909688	P890003	254
00613994909565	P890003	254
00643169369030	P890003	254
00643169334717	P890003	258
00643169341050	P890003	258
00643169107052	P890003	258
00613994524232	P890003	260
00643169703223	P890003	260
00643169703193	P890003	260
00643169486744	P890003	269
00763000367893	P890003	269
00763000367886	P890003	269
00643169469891	P890003	269
00643169402904	P890003	284
00643169341067	P890003	284
00643169441101	P890003	285
00643169325715	P890003	290
00643169325678	P890003	290
00643169325708	P890003	290
00643169325685	P890003	290
00643169325692	P890003	290
00643169459885	P890003	297
00643169460089	P890003	297
00643169367203	P890003	299
00643169452060	P890003	306
00643169469884	P890003	307
00643169527539	P890003	313
00763000305079	P890003	313
00643169431874	P890003	314
00643169838604	P890003	314
00643169703247	P890003	314
00643169312081	P890003	319
00643169552289	P890003	320
00643169552104	P890003	320
00643169569744	P890003	328
00643169666320	P890003	328
00643169376823	P890003	329
00643169705746	P890003	334
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