Product code NIK

Device name: Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
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 will be indicated for patients needing an ICD who also have moderate to severe heart failure and are indicated for cardiac resynchronization therapy.
Source: FDA openFDA device classification dataset

PMA, Device, Applicant table
PMA	Device	Applicant	Decision date
P010012S610	EasyTrak, Acuity Spiral and Acuity x4 Leads: ACuity Spiral Lead Model: 4592 Acuity x4 Lead Models: 4671, 4672, 4674, 467	Boston Scientific Corp	2026-06-03
P010012S609	MOMENTUM, MOMENTUM X4, INOGEN, DYNAGEN, VIGILANT, VIGILANT X4, RESONATE, RESONATE X4, RESONATE HF	Boston Scientific Corp	2026-06-03
P010031S925	Cobalt MRI CRT-D (DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ); Cobalt XT MRI CRTD (DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ); Cobalt X	Medtronic Cardiac Rhythm Disease Management	2026-05-15
P010012S608	ACUITY™ X4 Suture Sleeve (aka Lead Stabilizer) (Model 4603); ACUITY™ X4 Flushing Tool/Wire Guide (Model 4604)	Boston Scientific Corp	2026-05-15
P010031S924	Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt	Medtronic Cardiac Rhythm Disease Management	2026-04-30
P010031S918	Cobalt MRI CRT-D (DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ); Cobalt XT MRI CRT-D (DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ); Crome M	Medtronic Cardiac Rhythm Disease Management	2026-04-30
P010031S923	Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt	Medtronic Cardiac Rhythm Disease Management	2026-04-28
P030054S444	Optisure Leads (LDA210, LDA210Q, LDA220Q, LDP210Q, LDP220Q, LDA230Q, LDP230Q); Quartet Leads (1456Q, 1457Q, 1458Q, 1456Q	ABBOTT MEDICAL	2026-04-24
P030054S442	Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+	ABBOTT MEDICAL	2026-04-24
P010012S606	ACUITY Spiral (Model 4592); ACUITY X4 Straight (Model 4593); ACUITY X4 Straight (Model 4672); ACUITY X4 Spiral S (Model	Boston Scientific Corp	2026-04-22
P010012S594	Cardiac Resynchronization Therapy Defibrillators (CRT-D) RESONATE: G524, G525, G526, G528, G537, G547, G548, G424, G425,	Boston Scientific Corp	2026-04-21
P010012S604	Suture Sleeve Model 4603, 6402 , ACUITY X4 Flushing tool/Wire guide Model 4604, Lead Cap Model 6742, Torque Wrench, Mode	Boston Scientific Corp	2026-04-10
P010012S605	CONTAK CD, EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILL	Boston Scientific Corp	2026-04-01
P030054S443	Avant (CDHFA700Q, CDHFA700B, CDHFA700D, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800B, CDHFA800D, CDHFA800T); Gallant (	ABBOTT MEDICAL	2026-03-27
P010031S921	Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D	Medtronic Cardiac Rhythm Disease Management	2026-03-27
P010031S920	Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt	Medtronic Cardiac Rhythm Disease Management	2026-03-06
P010031S919	Cobalt MRI CRT-D (DTPB2Dl, DTPB2D4, DTPB2Ql, DTPB2QQ); Cobalt XT MRI CRT-D (DTPA2Dl, DTPA2D4, DTPA2Ql, DTPA2QQ); Crome M	Medtronic Cardiac Rhythm Disease Management	2026-03-04
P030054S435	Quartet; QuickFlex Micro	ABBOTT MEDICAL	2026-02-19
P030054S441	Avant (CDHFA700Q, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800T CDHFA600Q, CDHFA600T); Gallant (CDHFA500Q, CDHFA500T);	ABBOTT MEDICAL	2026-02-13
P010012S602	ACUITY™ X4 Straight/ model 4671; ACUITY X4 Straight/ model 4672; ACUITY X4 Spiral S/ model 4674; ACUITY X4 Spiral S/ mod	Boston Scientific Corp	2026-02-13
P010031S916	Amplia MRI CRT-D DTMB1D1, DTMB1D4 Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ Brava CRT-D DTBC1D1, DTBC1D4 Brava Quad CRT-D D	Medtronic Cardiac Rhythm Disease Management	2026-02-12
P010031S914	Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt	Medtronic Cardiac Rhythm Disease Management	2026-02-11
P010031S915	Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt	Medtronic Cardiac Rhythm Disease Management	2026-02-10
P010031S912	Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt	Medtronic Cardiac Rhythm Disease Management	2026-01-23
P010031S913	Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D	Medtronic Cardiac Rhythm Disease Management	2026-01-16
P010012S592	NG3 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds): DYNAGEN Models: G150, G151, G154, G156, G158; INOGEN Mode	Boston Scientific Corp	2026-01-08
P010031S911	Amplia MRI CRT-D DTMB1D1, DTMB1D4 Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ Brava CRT-D DTBC1D1, DTBC1D4 Brava Quad CRT-D D	Medtronic Cardiac Rhythm Disease Management	2026-01-05
P010031S905	Cobalt MRI CRT-D DTPB2D1, DTPB2D4 NIK Cobalt XT MRI CRT-D DTPA2D1, DTPA2D4 NIK Crome MRI CRT-D DTPC2D1, DTPC2D4	Medtronic Cardiac Rhythm Disease Management	2025-12-19
P010031S909	Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt	Medtronic Cardiac Rhythm Disease Management	2025-12-15
P010031S910	Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua	Medtronic Cardiac Rhythm Disease Management	2025-12-03

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
04035479182984	Rivacor Aura HF-T QP	BIOTRONIK SE & Co. KG	2026-04-20
04035479182861	Rivacor Sky HF-T	BIOTRONIK SE & Co. KG	2026-04-20
04035479182854	Rivacor Sky HF-T QP	BIOTRONIK SE & Co. KG	2026-04-20
04035479182816	Acticor Sky HF-T	BIOTRONIK SE & Co. KG	2026-04-20
04035479182809	Acticor Sky HF-T QP	BIOTRONIK SE & Co. KG	2026-04-20
00763000059545	Viva™ XT CRT-D	MEDTRONIC, INC.	2017-10-21
00643169720251	Viva™ XT CRT-D	MEDTRONIC, INC.	2017-09-15
00643169720268	Viva™ S CRT-D	MEDTRONIC, INC.	2017-09-15
00643169720190	Viva™ Quad XT CRT-D	MEDTRONIC, INC.	2017-09-15
00643169720138	Viva™ Quad XT CRT-D	MEDTRONIC, INC.	2017-09-15
04035479145316	BIOTRONIK	BIOTRONIK SE & Co. KG	2017-08-01
00643169929388	Viva™ S CRT-D	MEDTRONIC, INC.	2017-05-22
00643169929371	Viva™ S CRT-D	MEDTRONIC, INC.	2017-05-22
00643169929319	Viva™ Quad XT CRT-D	MEDTRONIC, INC.	2017-05-22
00643169929401	Viva™ Quad S CRT-D	MEDTRONIC, INC.	2017-05-14
00643169929326	Viva™ Quad XT CRT-D	MEDTRONIC, INC.	2017-05-14
00643169713697	MedtronicLongevity	MEDTRONIC, INC.	2016-10-22
00643169530218	Viva™ Quad S CRT-D	MEDTRONIC, INC.	2015-05-15
00643169530201	Viva™ Quad S CRT-D	MEDTRONIC, INC.	2015-05-15
00613994987082	Secura® DR	MEDTRONIC, INC.	2014-09-23
00613994714596	Protecta™ XT VR	MEDTRONIC, INC.	2014-09-23
00643169007246	Viva™ XT CRT-D	MEDTRONIC, INC.	2014-09-23
00643169018013	Viva™ Quad XT CRT-D	MEDTRONIC, INC.	2014-09-23
00681490197885	SMARTMAGNET™	MEDTRONIC, INC.	2014-09-23
00613994987037	Protecta™ CRT-D	MEDTRONIC, INC.	2014-09-23
00613994987020	Protecta™ DR	MEDTRONIC, INC.	2014-09-23
00613994987006	Protecta™ XT CRT-D	MEDTRONIC, INC.	2014-09-23
00613994986986	Protecta™ XT VR	MEDTRONIC, INC.	2014-09-23
00613994714701	Consulta® CRT-D	MEDTRONIC, INC.	2014-09-23
00613994714619	Protecta™ CRT-D	MEDTRONIC, INC.	2014-09-23

Product code NIK

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