SelectSecure Lead

FDA Premarket Approval P030036 S132

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

3830 outer coil cell operating system (cos) conversion and legacy cos improvements

• Device: SelectSecure Lead
• Generic Name: Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes
• Applicant: MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
• Date Received: 2021-08-13
• Decision Date: 2021-08-20
• PMA: P030036
• Supplement: S132
• Product Code: NVN
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: Yes
• Applicant Address: MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 Coral Sea Street N.e. mounds View, MN 55112

Supplemental Filings

Supplement Number	Date	Supplement Type
P030036		Original Filing
S141	2022-11-21	30-day Notice
S140	2022-11-16	30-day Notice
S139	2022-07-22	Normal 180 Day Track
S138	2022-05-20	30-day Notice
S137	2022-04-14	30-day Notice
S136	2022-02-16	30-day Notice
S135	2022-01-28	30-day Notice
S134	2021-11-19	30-day Notice
S133	2021-11-18	30-day Notice
S132	2021-08-13	30-day Notice
S131	2021-08-09	30-day Notice
S130	2021-02-05	30-day Notice
S129	2021-01-12	30-day Notice
S128	2020-12-01	30-day Notice
S127
S126	2020-11-18	30-day Notice
S125	2020-11-13	30-day Notice
S124	2020-10-23	30-day Notice
S123	2020-09-17	30-day Notice
S122	2020-07-09	30-day Notice
S121	2020-06-26	30-day Notice
S120	2020-05-04	30-day Notice
S119
S118	2020-02-20	30-day Notice
S117	2020-01-17	30-day Notice
S116	2019-12-17	30-day Notice
S115	2019-11-18	30-day Notice
S114
S113	2019-08-22	30-day Notice
S112	2019-07-01	30-day Notice
S111
S110	2019-06-10	30-day Notice
S109	2019-05-06	30-day Notice
S108	2019-02-28	30-day Notice
S107	2018-11-02	30-day Notice
S106
S105	2018-10-23	30-day Notice
S104	2018-10-18	30-day Notice
S103	2018-09-26	30-day Notice
S102	2018-06-01	30-day Notice
S101	2018-05-15	30-day Notice
S100	2018-04-13	Normal 180 Day Track
S099	2018-02-22	30-day Notice
S098	2017-12-04	Real-time Process
S097	2017-11-20	30-day Notice
S096	2017-08-07	30-day Notice
S095	2017-05-18	Normal 180 Day Track
S094	2017-04-03	Normal 180 Day Track
S093	2017-01-25	Real-time Process
S092	2016-12-06	Normal 180 Day Track
S091	2016-12-06	Normal 180 Day Track
S090	2016-11-28	30-day Notice
S089	2016-11-14	30-day Notice
S088	2016-11-02	Normal 180 Day Track
S087	2016-10-05	30-day Notice
S086	2016-07-18	30-day Notice
S085	2016-06-24	30-day Notice
S084	2015-12-28	30-day Notice
S083	2015-12-28	30-day Notice
S082	2015-12-23	Normal 180 Day Track
S081	2015-12-22	30-day Notice
S080	2015-10-23	30-day Notice
S079	2015-07-20	30-day Notice
S078	2015-04-17	30-day Notice
S077	2015-02-09	30-day Notice
S076	2015-01-21	30-day Notice
S075
S074	2014-08-27	30-day Notice
S073	2014-08-08	30-day Notice
S072	2014-07-24	30-day Notice
S071	2014-02-27	30-day Notice
S070	2014-01-29	30-day Notice
S069	2013-12-24	30-day Notice
S068	2013-12-19	30-day Notice
S067	2013-11-22	30-day Notice
S066	2013-10-30	30-day Notice
S065	2013-10-24	30-day Notice
S064	2013-09-30	30-day Notice
S063	2013-09-26	30-day Notice
S062	2013-09-17	30-day Notice
S061	2013-09-13	30-day Notice
S060
S059	2013-05-21	30-day Notice
S058	2013-05-17	Real-time Process
S057	2013-04-30	30-day Notice
S056	2013-04-10	Normal 180 Day Track No User Fee
S055	2013-03-22	30-day Notice
S054	2013-03-20	30-day Notice
S053	2013-02-01	Special (immediate Track)
S052	2012-11-21	30-day Notice
S051	2012-10-26	Real-time Process
S050	2012-10-22	30-day Notice
S049	2012-09-28	30-day Notice
S048	2012-09-21	30-day Notice
S047	2012-09-04	30-day Notice
S046	2012-08-03	30-day Notice
S045	2012-07-13	30-day Notice
S044	2012-06-20	30-day Notice
S043	2012-06-11	30-day Notice
S042	2012-03-09	30-day Notice
S041	2012-02-29	30-day Notice
S040	2012-02-06	Normal 180 Day Track No User Fee
S039	2011-12-09	135 Review Track For 30-day Notice
S038	2011-11-25	30-day Notice
S037	2011-11-21	Normal 180 Day Track
S036	2011-07-18	30-day Notice
S035	2011-07-08	30-day Notice
S034	2011-06-28	30-day Notice
S033	2011-06-08	30-day Notice
S032	2011-06-08	135 Review Track For 30-day Notice
S031
S030	2011-04-26	30-day Notice
S029	2011-04-22	30-day Notice
S028	2011-04-12	30-day Notice
S027	2011-03-22	135 Review Track For 30-day Notice
S026	2011-02-28	30-day Notice
S025	2010-11-12	30-day Notice
S024	2010-10-26	30-day Notice
S023
S022	2010-07-30	Normal 180 Day Track No User Fee
S021	2010-07-15	30-day Notice
S020	2010-07-15	30-day Notice
S019	2010-07-15	30-day Notice
S018	2010-06-28	135 Review Track For 30-day Notice
S017	2010-06-09	30-day Notice
S016	2010-03-29	30-day Notice
S015	2010-01-19	30-day Notice
S014	2010-01-15	Real-time Process
S013	2009-03-17	Real-time Process
S012	2009-02-05	30-day Notice
S011	2008-12-11	30-day Notice
S010	2008-11-03	30-day Notice
S009	2008-08-22	135 Review Track For 30-day Notice
S008	2008-07-31	30-day Notice
S007	2008-06-17	30-day Notice
S006	2008-04-14	30-day Notice
S005	2008-03-24	30-day Notice
S004	2007-12-31	Normal 180 Day Track
S003	2007-02-26	135 Review Track For 30-day Notice
S002	2006-09-07	Special (immediate Track)
S001	2006-05-10	135 Review Track For 30-day Notice

NIH GUDID Devices

Device ID	PMA	Supp
00885074407968	P030036	000
00613994520784	P030036	000
00613994119957	P030036	000
00885074406428	P030036	000
00613994567611	P030036	013
00613994726117	P030036	022
00643169279186	P030036	040
00643169279193	P030036	040
00643169279209	P030036	040
00643169279292	P030036	040
00643169535848	P030036	073
00643169535855	P030036	073
00643169535879	P030036	073
00643169535886	P030036	073
00643169857674	P030036	088
00643169857698	P030036	088
00643169857681	P030036	088
00763000130794	P030036	100
00763000130800	P030036	100
00763000130817	P030036	100
00763000740276	P030036	139
00763000740269	P030036	139
00763000740252	P030036	139