Product code OSR

Device name: Pacemaker/Icd/Crt Non-Implanted Components
Medical specialty: Unknown
Device class: 3
Review panel: CV
Implant: Y
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Ineligible
Definition: Pacemaker/ICD/CRT non-implanted components provide programming, interrogation, printing, remote monitoring, and communication between the pulse generator and the health care provider.
Source: FDA openFDA device classification dataset

PMA, Device, Applicant table
PMA	Device	Applicant	Decision date
P150035S028	AVEIR™ Patient Transmitter (model, LSRM01), AVEIR™ Patient Transmitter Software (model, LSRM1000 v 1.0), AVEIR Patient T	ABBOTT MEDICAL	2025-09-24
P050023S197	CardioMessenger Smart 4G	Biotronik, Inc.	2025-08-22
P950037S252	PSW 2303.U, NEO 2303.U	Biotronik, Inc.	2023-12-13
P150033S162	CareLink SmartSync™ Micra VR App, CareLink SmartSync™ Micra AV App	Medtronic, Inc.	2023-01-18
P950037S242	PSW 2202.U and NEO 2202.U	Biotronik, Inc.	2023-01-12
P950037S234	PSW 2201.U/1 and NEO 2201.U/1	Biotronik, Inc.	2022-04-11
P830060S084	Implantable Pulse Generator Test Magnet	Boston Scientific	2021-04-16
P950037S213	Renamic Neo Programmer	Biotronik, Inc.	2021-03-08
P890003S368	MYCARELINK PATIENT MONITOR MODEL	Medtronic, Inc.	2017-06-09
P890003S350	CareLink Programmer (Model 2090), Encore Programmer (Model 29901)	Medtronic, Inc.	2016-04-28
P910077S151	LATITUDE PATIENT MANAGEMENT SYSTEM, WAVE COMMUNICATOR MODEL 6290; NXT SYSTEM SEVER SOFTWARE MODEL 6460	Boston Scientific	2016-02-05
P890003S344	MEDTRONIC CARELINK MONITOR, MYCARELINK PATIENT MONITOR	Medtronic, Inc.	2016-02-05
P010031S478	BRAVA,BRAVA QUAD,CONCERTO II,CONSULTA,MAXIMO II,PROTECTA,PROTECTA XT,VIVA QUAD S, VIVA QUAD XT,VIVA S, VIVA XT CRT-DS, C	Medtronic Cardiac Rhythm Disease Management	2015-10-19
P010031S510	MAXIMO II CRT-D, CONCERTO, CONCERTO II, CONSULTA, INSYNC II MARQUIS, INSYNC III MARQUIS, INSYNC MAXIMO, INSYNC SENTRY,	Medtronic Cardiac Rhythm Disease Management	2015-10-07
P910077S149	LATITUDE NXT PATIENT MANAGEMENT SYSTEM	Boston Scientific	2015-07-21
P010012S387	COGNIS,ENERGEN,PUNCTUA,INCEPTA,ORIGEN,INOGEN,DYNAGEN,AUTOGEN CRT-DS	Boston Scientific Corp	2015-07-21
P910077S150	LATITUDE INDUCTIVE COMMUNICATOR ; LATITUDE PROGRAMMER/RECORDER/MONITOR (PRM)	Boston Scientific	2015-07-20
P950037S148	ACTROS/AXIOS DR/SR/SLR/D/S, BA03 DDDR, CYLOS DR/DR-T/VR, DROMOS DR/SR/SL, KAIROS DR/SR/SL/D/S, PHILOS DR/D	Biotronik, Inc.	2015-04-09
P890003S313	MYCARELINK SMART MONITOR AND THE MYCARELINK HEART APPLICATION	Medtronic, Inc.	2015-01-26
P910077S148	LATITUDE CONSULT SYSTEM	Boston Scientific	2015-01-06
P010031S464	BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC II PROTECT ICD, INSYNC III MARQUI	Medtronic Cardiac Rhythm Disease Management	2014-11-07
P980049S102	PARADYM RF VR 9250 PARADYM RF DR 9550	MicroPort CRM USA, Inc.	2014-11-06
P910077S147	LATITUDE CONSULT SYSTEM	Boston Scientific	2014-11-06
P910077S144	VENTAK PRX AND VENTAK MINI SYSTEMS	Boston Scientific	2014-08-12
P890003S307	MYCARELINK PATIENT MONITOR	Medtronic, Inc.	2014-05-29
P890003S304	REVEAL LINQ SOFTWARE MODEL SWO26	Medtronic, Inc.	2014-04-30
P910077S139	MODEL 3140 ZOOM WIRELESS TRANSMITTER AND MODEL 3120 ZOOM LATITUDE PROGRAMMER/RECORDER/MONITOR (PRM)	Boston Scientific	2014-04-11
P910077S138	LATTITUDE CONSULT SYSTEM	Boston Scientific	2014-03-20
P890003S284	REVEAL DX, REVEAL XT	Medtronic, Inc.	2013-10-15
P890003S283	MEDTRONIC MODELS 2490C CARELINK REMOTE HOME MONITORS	Medtronic, Inc.	2013-10-07

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
04035479190538	SW HMSC 3.66	BIOTRONIK SE & Co. KG	2026-05-28
00763000181185	NA	MEDTRONIC, INC.	2023-01-30
00763000181345	NA	MEDTRONIC, INC.	2021-06-12
00763000033217	MyCareLink™	MEDTRONIC, INC.	2019-10-13
00763000033194	MyCareLink™	MEDTRONIC, INC.	2019-10-13
00643169552043	MyCareLink™	MEDTRONIC, INC.	2019-10-13
00643169725386	MyCareLink™	MEDTRONIC, INC.	2017-11-16
00643169855519	NA	MEDTRONIC, INC.	2017-05-25
00643169833753	CareLink SmartSync™ PSA Application	MEDTRONIC, INC.	2017-05-25
00643169725362	MyCareLink™	MEDTRONIC, INC.	2017-05-06
00643169725195	MyCareLink™	MEDTRONIC, INC.	2017-05-01
00643169658134	MyCareLink™	MEDTRONIC, INC.	2017-01-01
00643169705746	MyCareLink™	MEDTRONIC, INC.	2016-05-28
00643169705753	MyCareLink™	MEDTRONIC, INC.	2016-05-28
00643169658127	MyCareLink™	MEDTRONIC, INC.	2016-01-04
00643169657885	MyCareLink™	MEDTRONIC, INC.	2015-12-18
00613994127631	Medtronic CareLink® Programmer	MEDTRONIC, INC.	2014-09-23
00613994175403	Medtronic CareLink® Programmer	MEDTRONIC, INC.	2014-09-23
00613994434937	Medtronic CareLink® Programmer	MEDTRONIC, INC.	2014-09-23
00613994435125	NA	MEDTRONIC, INC.	2014-09-23
00721902710353	NA	MEDTRONIC, INC.	2014-09-23
00721902710346	NA	MEDTRONIC, INC.	2014-09-23
00721902546655	NA	MEDTRONIC, INC.	2014-09-23
00721902290138	NA	MEDTRONIC, INC.	2014-09-23
00721902290121	NA	MEDTRONIC, INC.	2014-09-23
00681490501880	NA	MEDTRONIC, INC.	2014-09-23
00681490142656	NA	MEDTRONIC, INC.	2014-09-23
00613994501011	NA	MEDTRONIC, INC.	2014-09-23
00613994909688	CareLink Encore™	MEDTRONIC, INC.	2014-09-23
00643169369030	CareLink Encore™	MEDTRONIC, INC.	2014-09-23

Product code OSR

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