Product code LWS

Device name: Implantable Cardioverter Defibrillator (Non-Crt)
Medical specialty: Unknown
Device class: 3
Review panel: CV
Implant: Y
Life sustaining/supporting: Y
GMP exempt: N
Third party review: N
Summary malfunction reporting: Ineligible
Definition: These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.
Source: FDA openFDA device classification dataset

PMA, Device, Applicant table
PMA	Device	Applicant	Decision date
P980016S963	Evera MRI DF-1 ICD (DDMB1D1, DDMC3D1, DVMB1D1, DVMC3D1); Evera MRI ICD (DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4); Evera S DR	Medtronic Cardiac Rhythm Disease Management	2026-07-31
P980016S962	Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I	Medtronic Cardiac Rhythm Disease Management	2026-07-31
P980016S961	Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I	Medtronic Cardiac Rhythm Disease Management	2026-07-31
P220012S075	Aurora EV-ICD (DVEA3E4)	Medtronic, Inc.	2026-07-31
P220012S074	Aurora EV ICD (DVEA3E4)	Medtronic, Inc.	2026-07-31
P960040S516	ICD INOGEN™ VR DF4 (D010); ICD INOGEN™ VR DF1/IS1 (D011); ICD INOGEN™ DR DF4/IS1 (D012); ICD INOGEN™ DR DF1/IS1 (D013);	Boston Scientific	2026-07-23
P110042S215	S-ICD EMBLEM™ GEN 2 (A209); S-ICD EMBLEM™ MRI (A219)	Boston Scientific Corporation	2026-07-23
P980016S960	Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4; Crome MRI ICD D	Medtronic Cardiac Rhythm Disease Management	2026-07-22
P910023S482	Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs	ABBOTT MEDICAL	2026-07-21
P980016S959	Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Primo MRI DR ICD, Primo MRI VR ICD,	Medtronic Cardiac Rhythm Disease Management	2026-07-16
P220012S073	Aurora EV ICD	Medtronic, Inc.	2026-07-16
P910023S486	Avant (CDVRA700Q, CDVRA700T); Neutrino NxT (CDVRA800Q, CDVRA800T, CDVRA600Q, CDVRA600T); Gallant (CDVRA500Q, CDVRA500T);	ABBOTT MEDICAL	2026-07-09
P110042S210	EMBLEM™ S-ICD Electrode (Lead) Model 3501	Boston Scientific Corporation	2026-07-07
P980023S148	Plexa ProMRI S 60, Plexa ProMRI S 65, Plexa ProMRI S 75, Plexa ProMRI SD 60/16, Plexa ProMRI SD 65/16, Plexa ProMRI SD 6	Biotronik, Inc.	2026-07-01
P960040S513	TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA	Boston Scientific	2026-07-01
P910077S198	LATITUDE™ NXT Remote Patient Management System; LATITUDE™ NXT System Server Software Model 6460	Boston Scientific	2026-07-01
P110042S214	Emblem S-ICD (A209); Emblem MRI S-ICD (A219)	Boston Scientific Corporation	2026-07-01
P110042S211	EMBLEM S-ICD	Boston Scientific Corporation	2026-07-01
P950022S154	Durata Leads; Optisure Leads; UltiSync Leads	ABBOTT MEDICAL	2026-06-26
P980016S955	Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4 Evera S DR ICD DDBC3D4 Evera S VR ICD DVBC3D4 Evera XT VR ICD DVBB1D4 M	Medtronic Cardiac Rhythm Disease Management	2026-06-25
P220012S069	Aurora EV ICD DVEA3E4	Medtronic, Inc.	2026-06-25
P980023S147	Acticor Sky VR-T (481989); Rivacor Sky VR-T (481984); Rivacor Rise VR-T (482020); Rivacor Aura VR-T (482015); Acticor Sk	Biotronik, Inc.	2026-06-24
P910073S192	RELIANCE™ S Passive Single Coil, RELIANCE S Active Fix Single Coil, RELIANCE Passive Dual Coil, RELIANCE Active Fix Dual	Boston Scientific	2026-06-09
P960040S514	INOGEN, DYNAGEN, MOMENTUM, VIGILANT EL, PERCIVA MINI, RESONATE EL, PERCIVA HF, RESONATE HF	Boston Scientific	2026-06-03
P910073S191	Endotak Reliance Leads (0128, 0137, 0138, 0147, 0148, 0157, 0158); Endotak Reliance 4-Site Leads (0262, 0263, 0265, 0266	Boston Scientific	2026-06-03
P110042S213	S-ICD Electrode Model: 3501	Boston Scientific Corporation	2026-06-03
P110042S212	EMBLEM, EMBLEM MRI	Boston Scientific Corporation	2026-06-03
P980016S958	Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I	Medtronic Cardiac Rhythm Disease Management	2026-05-15
P930035S037	Hex Wrench (#2) (Model 6501)	Boston Scientific	2026-05-15
P910077S199	DF-1 Plug (Model 6996)	Boston Scientific	2026-05-15

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00643169300842	NA	MEDTRONIC, INC.	2016-08-29
00643169335561	Sprint Quattro®	MEDTRONIC, INC.	2016-08-07
00613994220288	NA	MEDTRONIC, INC.	2015-06-10
00613994618177	NA	MEDTRONIC, INC.	2014-09-23
00613994987099	Consulta® CRT-D	MEDTRONIC, INC.	2014-09-23
00613994987013	Protecta™ VR	MEDTRONIC, INC.	2014-09-23
00613994986993	Protecta™ XT DR	MEDTRONIC, INC.	2014-09-23
00613994740922	Sprint Quattro Secure® DXAC/DSP	MEDTRONIC, INC.	2014-09-23
00613994740915	Sprint Quattro Secure® DXAC/DSP	MEDTRONIC, INC.	2014-09-23
00613994714800	Maximo® II CRT-D	MEDTRONIC, INC.	2014-09-23
00613994714718	Secura® VR	MEDTRONIC, INC.	2014-09-23
00613994714695	Secura® DR	MEDTRONIC, INC.	2014-09-23
00613994714626	Protecta™ VR	MEDTRONIC, INC.	2014-09-23
00613994714602	Protecta™ DR	MEDTRONIC, INC.	2014-09-23
00613994714589	Protecta™ XT CRT-D	MEDTRONIC, INC.	2014-09-23
00613994714572	Protecta™ XT DR	MEDTRONIC, INC.	2014-09-23
00613994501035	NA	MEDTRONIC, INC.	2014-09-23
00613994446640	Secura® VR	MEDTRONIC, INC.	2014-09-23
00613994446633	Secura® DR	MEDTRONIC, INC.	2014-09-23
00613994446602	Maximo® II DR	MEDTRONIC, INC.	2014-09-23
00613994446367	Sprint Quattro Secure S™	MEDTRONIC, INC.	2014-09-23
00613994446350	Sprint Quattro Secure S™	MEDTRONIC, INC.	2014-09-23
00613994446343	Sprint Quattro Secure S™	MEDTRONIC, INC.	2014-09-23
00613994446336	Sprint Quattro Secure S™	MEDTRONIC, INC.	2014-09-23
00613994446114	Sprint Quattro Secure S™ DXAC/DSP	MEDTRONIC, INC.	2014-09-23
00613994446107	Sprint Quattro Secure S™ DXAC/DSP	MEDTRONIC, INC.	2014-09-23
00613994446091	Sprint Quattro Secure S™ DXAC/DSP	MEDTRONIC, INC.	2014-09-23
00613994446084	Sprint Quattro Secure S™ DXAC/DSP	MEDTRONIC, INC.	2014-09-23
00613994249890	Sprint Quattro Secure®	MEDTRONIC, INC.	2014-09-23
00613994249876	Sprint Quattro Secure®	MEDTRONIC, INC.	2014-09-23

Product code LWS

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