Product code NVZ

Device name: Pulse Generator, Permanent, Implantable
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: Intended as a permanent implant to deliver pacing pulses and other pacing therapies through pacing leads implanted in the heart.
Source: FDA openFDA device classification dataset

PMA, Device, Applicant table
PMA	Device	Applicant	Decision date
P980035S836	Astra S DR MRI IPG (X3DR01);Astra S SR MRI IPG (X3SR01);Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG (X1SR01); Azur	Medtronic, Inc.	2026-05-14
P980035S835	CareLink SmartSync™ Adapta™ Versa™ Sensia™ Application (D00U014)	Medtronic, Inc.	2026-05-06
P890003S485	CareLink SmartSync Platform Application (M01A01); CareLink SmartSync Common Application (M01A02); CareLink SmartSync Hos	Medtronic, Inc.	2026-05-06
P980035S834	Astra S DR MRI IPG (X3DR01); Astra S SR MRI IPG (X3SR01); Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG (X1SR01); Az	Medtronic, Inc.	2026-04-30
P980035S840	Astra S DR MRI IPG (X3DR01); Astra S SR MRI IPG (X3SR01); Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG (X1SR01); Az	Medtronic, Inc.	2026-04-23
P890003S486	CapSure VDD-2 Lead (5038L, 5038S), CapSure VDD-2 Lead (5038), Service Kit-Pacemaker Repair Kit (5873C)	Medtronic, Inc.	2026-04-15
P980035S838	Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Azure S DR MRI IPG; Azure S SR MRI IPG	Medtronic, Inc.	2026-03-27
P980035S837	Adapta, Versa, Sensia IPG (ADDR01, ADDR03, ADDRS1, SED01, SEDR01, SES01, VEDR01); Adapta, Versa, Sensia IPG (SEDRL1); Ad	Medtronic, Inc.	2026-03-27
P980035S832	Advisa DR IPG A4DR01 Advisa DR MRI IPG A2DR01 Advisa SR MRI IPG A3SR01	Medtronic, Inc.	2026-02-12
P980035S831	Adapta, Versa, Sensia IPG (ADDR01, ADDR03, ADDR06, ADDRL1, ADSR03, ADVDD01, SED01, SES01, VEDR01); Adapta, Versa, Sensia	Medtronic, Inc.	2026-02-10
P980035S829	Advisa DR IPG (A4DR01); Advisa DR MRI IPG (A2DR01); Advisa SR MRI IPG (A3SR01); Astra S DR MRI IPG (X3DR01); Astra S SR	Medtronic, Inc.	2026-02-10
P890003S484	CapSure VDD-2 Lead 5038, 5038L, 5038S Service Kit-Pacemaker Repair Kit 5873C Vitatron Brilliant S+ VDD Lead IMW14Q, IMW1	Medtronic, Inc.	2026-02-10
P980035S833	Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Attesta DR MRl IPG; Attesta DR MRl IPG;	Medtronic, Inc.	2026-01-28
P980035S830	Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Azure S DR MRI IPG; Azure S SR MRI IPG	Medtronic, Inc.	2026-01-23
P980035S828	Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Advisa DR IPG; Advisa DR MRI IPG; Advis	Medtronic, Inc.	2026-01-23
P980035S827	Adapta, Versa, Sensia IPG ADDR01, ADDRS1, ADSR03, SES01 LWP, NVZ Adapta, Versa, Sensia IPG SEDRL1 NVZ Adapta, Versa, Sen	Medtronic, Inc.	2025-12-03
P980035S826	Adapta, Versa, Sensia IPG ADDRL1, ADDRS1, VEDR01, ADDR03, ADSR03, ADDR01, ADSR06, ADSR01, ADVDD01, SEDR01, ADDR06, SESR0	Medtronic, Inc.	2025-12-03
P890003S483	CareLink SmartSync Device Manager Base 24970A	Medtronic, Inc.	2025-12-03
P890003S481	SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071	Medtronic, Inc.	2025-10-30
P980035S824	Advisa DR IPG; Advisa DR MRI IPG; Advisa SR MRI IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra	Medtronic, Inc.	2025-10-08
P980035S823	Advisa DR IPG; Advisa DR MRI IPG; Advisa SR MRI IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT SR MRI IPG; Astra	Medtronic, Inc.	2025-10-03
P980035S825	Adapta, Versa, Sensia IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Attesta DR	Medtronic, Inc.	2025-10-02
P980035S822	Advisa DR IPG; Advisa DR MRI IPG; Advisa SR MRI IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra	Medtronic, Inc.	2025-10-02
P950037S277	Edora 8 DR-T; Evity 8 DR-T; Enitra 8 DR-T; Enticos 8 DR-T; Evity 6 DR-T; Enitra 6 DR-T; Edora 8 DR; Enitra 6 DR; Edora 8	Biotronik, Inc.	2025-10-01
P980035S821	Astra S DR MRI IPG (X3DR01); Astra S SR MRI IPG (X3SR01); Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG (X1SR01); Az	Medtronic, Inc.	2025-09-05
P980035S820	Adapta, Versa, Sensia IPG ADDRL1, ADDRS1, ADSR06; Adapta, Versa, Sensia IPG SED01, SES01; Adapta, Versa, Sensia IPG SED	Medtronic, Inc.	2025-08-12
P980035S818	Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG	Medtronic, Inc.	2025-08-12
P890003S482	CareLink SmartSync Device Manager Base	Medtronic, Inc.	2025-08-12
P980035S817	Advisa DR IPG (A4DR01); Advisa DR MRI IPG (A2DR01); Advisa SR MRI IPG (A3SR01)	Medtronic, Inc.	2025-08-06
P980035S819	Adapta, Versa, Sensia IPG (SED01); Adapta, Versa, Sensia IPG (ADSR01, VEDR01); Adapta, Versa, Sensia IPG (ADVDD01); Adap	Medtronic, Inc.	2025-07-29

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00643169314153	Evera MRI™ XT VR SureScan®	MEDTRONIC, INC.	2015-09-21
00643169314139	Evera MRI™ S DR SureScan®	MEDTRONIC, INC.	2015-09-21
00643169314092	Evera MRI™ XT DR SureScan®	MEDTRONIC, INC.	2015-09-21
00643169530263	Evera™ XT DR	MEDTRONIC, INC.	2015-05-15
00643169474277	Versa®	MEDTRONIC, INC.	2015-02-05
00643169474260	Sensia®	MEDTRONIC, INC.	2015-02-05
00643169474253	Sensia®	MEDTRONIC, INC.	2015-02-05
00643169474222	Adapta®	MEDTRONIC, INC.	2015-02-05
00643169474178	Adapta® L	MEDTRONIC, INC.	2015-02-05
00643169474154	Adapta®	MEDTRONIC, INC.	2015-02-05
00613994763334	Versa™	MEDTRONIC, INC.	2014-09-23
00643169369030	CareLink Encore™	MEDTRONIC, INC.	2014-09-23
00643169018099	Evera™ XT DR	MEDTRONIC, INC.	2014-09-23
00643169018082	Evera™ XT DR	MEDTRONIC, INC.	2014-09-23
00613994909688	CareLink Encore™	MEDTRONIC, INC.	2014-09-23
00613994177957	Sensia™	MEDTRONIC, INC.	2014-09-23
00613994763259	Adapta™	MEDTRONIC, INC.	2014-09-23
00613994763242	Adapta™ L	MEDTRONIC, INC.	2014-09-23
00613994763235	Adapta™	MEDTRONIC, INC.	2014-09-23
00613994713650	Advisa DR MRI™ SureScan®	MEDTRONIC, INC.	2014-09-23
00613994524232	NA	MEDTRONIC, INC.	2014-09-23
00613994501011	NA	MEDTRONIC, INC.	2014-09-23
00613994295040	Adapta™ S	MEDTRONIC, INC.	2014-09-23
00613994222190	Adapta™	MEDTRONIC, INC.	2014-09-23
00613994222152	Adapta™	MEDTRONIC, INC.	2014-09-23
00613994222138	Sensia™	MEDTRONIC, INC.	2014-09-23
00613994222114	Versa™	MEDTRONIC, INC.	2014-09-23
00613994222091	Adapta™ S	MEDTRONIC, INC.	2014-09-23
00613994222084	Adapta™ L	MEDTRONIC, INC.	2014-09-23
00613994222046	Adapta™	MEDTRONIC, INC.	2014-09-23

Product code NVZ

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