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
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
P910073S190	ACUITY™ X4 Connector Tool (Model 4625); RELIANCE™ 4-FRONT Suture Sleeve (aka Lead Stabilizer) (Model 6403); Lead Cap Kit	Boston Scientific	2026-05-15
P830060S093	Vein Pick (Model 6541)	Boston Scientific	2026-05-15
P980023S145	Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor Rise VR-T, Rivacor Aura VR-T, Acticor Sky VR-T DX, Rivacor Sky VR-T DX, Riva	Biotronik, Inc.	2026-05-07
P980016S957	Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD; Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Eve	Medtronic Cardiac Rhythm Disease Management	2026-04-30
P980016S951	Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2DL DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI IC	Medtronic Cardiac Rhythm Disease Management	2026-04-30
P220012S072	Aurora EV-ICD	Medtronic, Inc.	2026-04-30
P980016S956	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	2026-04-28
P220012S071	Aurora EV ICD, Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD	Medtronic, Inc.	2026-04-28
P950022S152	Durata Leads (7120, 7121, 7122, 7120Q, 7121Q, 7122Q, 7170, 7170Q, 7172Q, 7171Q)	ABBOTT MEDICAL	2026-04-24
P910023S484	Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs	ABBOTT MEDICAL	2026-04-24
P910073S189	RELIANCE S Active Fix Single Coil IS-1/DF-1 59cm (Model 0137); RELIANCE S Active Fix Single Coil IS-1/DF-1 64cm (Model 0	Boston Scientific	2026-04-22
P960040S507	Implantable Cardioverter Defibrillators (ICD) RESONATE: D420, D421, D432, D433, D520, D521, D532, D533; MOMENTUM: D120,	Boston Scientific	2026-04-21
P980050S146	Transvene CS/SVC Lead (6937A)	Medtronic, Inc.	2026-04-15
P900061S176	End Cap (6701), Sizing Sleeve (6920), Upsizing Sleeve (6925)	Medtronic Cardiac Rhythm Disease Management	2026-04-15
P220012S070	Epsila EV Extravascular Lead	Medtronic, Inc.	2026-04-15
P930035S036	Wrench Kit Model 6501	Boston Scientific	2026-04-10
P910077S197	Lead Port Plug Model 6996	Boston Scientific	2026-04-10
P910073S188	• ACUITY X4 Connector Tool Model 4625 • AICD Lead Stylets Firm Model 6971 • AICD Lead Stylets Soft Model 6972 • Suture S	Boston Scientific	2026-04-10
P830060S092	Vein Pick Model 6541	Boston Scientific	2026-04-10
P960040S512	VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM	Boston Scientific	2026-04-01
P980016S954	Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD	Medtronic Cardiac Rhythm Disease Management	2026-03-27
P910023S485	Avant (CDVRA700Q, CDDRA700Q, CDVRA700T, CDDRA700T); Neutrino NxT (CDVRA800Q, CDVRA600Q CDDRA800Q, CDDRA600Q CDVRA600T, C	ABBOTT MEDICAL	2026-03-27
P980016S953	Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD; Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR I CD; Ev	Medtronic Cardiac Rhythm Disease Management	2026-03-06
P910073S187	ENDOTAK RELIANCE™ / RELIANCE 4-FRONT™ pace/sense defibrillation leads	Boston Scientific	2026-03-06
P220012S068	Aurora EV ICD; Epsila EV Extravascular Lead	Medtronic, Inc.	2026-03-06
P980023S144	Acticor Sky VR-T (481989); Rivacor Sky VR-T (481984); Rivacor Rise VR-T (482020); Rivacor Aura VR-T (482015); Acticor Sk	Biotronik, Inc.	2026-03-05
P980016S952	Cobalt MRI ICD (DDPB3Dl, DDPB3D4, DVPB3Dl, DVPB3D4); Cobalt XT MRI ICD (DDPA2Dl, DDPA2D4, DVPA2Dl, DVPA2D4); Crome MRI I	Medtronic Cardiac Rhythm Disease Management	2026-03-04

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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