ClearanceBrief
Product code NVZ ยท Class 3

Pulse Generator, Permanent, Implantable

0510(k)s in 12 months (0 all time)
3recalls in 12 months (43 all time)
0recalls that name a 510(k)
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Top companies in NVZ

DateFirm and productCodeLinked 510(k)
Oct 27, 2026Medtronic, Inc.
CareLink SmartSync Device Manager App, Model M01A02, Pulse generator, permanent, implantable
Open, Classified
NVZNone listed
Oct 27, 2026Medtronic, Inc.
CareLink SmartSync, RF Head Patient Connector, Model 24967, Pulse generator, permanent, implantable
Open, Classified
NVZNone listed
Oct 27, 2026Medtronic, Inc.
CareLink SmartSync Programmer, Model 24970A, Pulse generator, permanent, implantable
Open, Classified
NVZNone listed
Jul 23, 2025Medtronic, Inc.
Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia applica
Open, Classified
NVZNone listed
Jul 23, 2025Medtronic, Inc.
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia appli
Open, Classified
NVZNone listed
Jun 6, 2025Medtronic, Inc.
Azure S DR MRI SureScan, Product number W3DR01
Open, Classified
NVZNone listed
Nov 26, 2024Abbott Medical
Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitter configured for multiple patient use. It can receive inform
Open, Classified
NVZNone listed
Nov 26, 2024Abbott Medical
Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net" Patient Care Network (PCN) to facili
Open, Classified
NVZNone listed
Sep 13, 2024Medtronic Inc.
2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Product Description: PROGRAMMER 209031 PORTABLE CRM; c) 2
Open, Classified
NVZNone listed
Nov 8, 2021Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
Terminated
NVZNone listed
May 7, 2021St. Jude Medical, Cardian Rhythm Management Division
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
Open, Classified
NVZNone listed
May 7, 2021St. Jude Medical, Cardian Rhythm Management Division
ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
Open, Classified
NVZNone listed
Jul 10, 2020Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06
Open, Classified
NVZNone listed
Jul 10, 2020Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05
Open, Classified
NVZNone listed
Jul 10, 2020Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04
Open, Classified
NVZNone listed
Jul 10, 2020Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Azure S SR MRI, Model Number W3SR01
Open, Classified
NVZNone listed
Jul 10, 2020Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01
Open, Classified
NVZNone listed
Jul 10, 2020Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Azure S DR MRI, Model Number W3DR01
Open, Classified
NVZNone listed
Jul 10, 2020Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
Open, Classified
NVZNone listed
Jul 10, 2020Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Patient Connector, Model Number 24967
Open, Classified
NVZNone listed
Jan 22, 2020St Jude Medical, Cardiac Rhythm Management Division
Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 (05414734506045), CD1377-36C (05414734507622), CD2277-36Q (0541
Terminated
NVZNone listed
Feb 14, 2019Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1, E60A1 (c) G-series, Model Numbers: G70A1, G70A2 (d) Q-series, Model Numbers: Q50
Open, Classified
NVZNone listed
Feb 14, 2019Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
Open, Classified
NVZNone listed
Feb 14, 2019Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1
Open, Classified
NVZNone listed
Feb 14, 2019Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL1
Open, Classified
NVZNone listed
Feb 14, 2019Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD01
Open, Classified
NVZNone listed
Feb 14, 2019Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR01 (b) Model Number ATDRL1 (c) Model Number ATDRS1
Open, Classified
NVZNone listed
Feb 14, 2019Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01 (b) Model Number ADDR01 (c) Model Number ADDR03 (d) Model Number ADDR06 (e) Model Number ADDRL1 (f
Open, Classified
NVZNone listed
Jul 14, 2017Medtronic Inc., Cardiac Rhythm and Heart Failure
MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic patient implanted heart device. The reader is a portable electronic device that communicates with an implanted he
Terminated
NVZNone listed
Jul 14, 2017Medtronic Inc., Cardiac Rhythm and Heart Failure
MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic device that interfaces with Medtronic implanted
Terminated
NVZNone listed
Jul 5, 2016Medtronic Inc., Cardiac Rhythm and Heart Failure
Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitoring system that interrogates implanted devices and transmits the data to the Care L
Terminated
NVZNone listed
Mar 31, 2016Medtronic Inc., Cardiac Rhythm and Heart Failure
Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (2020B) Product Usage: The 2490C CareLink Home Monitors and 2020B CareLink Express Monitors are remote monitoring systems t
Terminated
NVZNone listed
Sep 28, 2015St Jude Medical Cardiac Rhythm Management Division
Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's.
Terminated
NVZNone listed
Jan 9, 2015St Jude Medical Cardiac Rhythm Management Division
Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter
Terminated
NVZNone listed
Apr 29, 2011Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic, Kappa 600 KDR600,KDR601,KDR603,KDR606,KDR651,KDR653 The devices are implantable pulse generators (IPG) used to detect bradycardia events and provide pacing support. Within each product fam
Terminated
NVZNone listed
Aug 11, 2010Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic Carelink Monitor Model 2490C. The Medtronic CareLink Monitor Model 2490C is designed to automatically gather information from the implanted heart device. This automatic wireless communicatio
Terminated
NVZNone listed
Sep 24, 2009ela Medical Llc
Sorin Group Reply DR Rate responsive dual-chamber pacemaker. Made in Italy by: Sorin BioMedica CRM S.r.l., Via Crescentino s.n., 13040 Saluggia (VC) Italy. ELA Medical, Inc., 14401 West 65th Way, A
Terminated
NVZNone listed
Jun 11, 2009Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber atrial sensing, ventricular sensing and pacing Pacemaker, models KVDD701 and KVDD901.
Terminated
NVZNone listed
Jun 11, 2009Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber Rate Responsive Pacemaker, models KDR601, KDR603, KDR606, KDR651, KDR653, KDR701, KDR703, KDR706, KDR721, and KDR921
Terminated
NVZNone listed
Jun 11, 2009Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber Pacemaker, models KD701, KD703, and KD706.
Terminated
NVZNone listed
Jun 11, 2009Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Single Chamber Rate Responsive Pacemaker; models KSR701, KSR703, KSR706, KSR901, KSR903, and KSR906.
Terminated
NVZNone listed
Jul 7, 2007Medtronic Inc. Cardiac Rhythm Managment
Vitatron T-Series Dual Chamber pacemaker T60 DR, model T60A1. The Vitatron C60 DR is a dual chamber rate responsive pacemaker (activity sensing using an accelerometer) for permanent atrial and ventric
Terminated
NVZNone listed
Jul 7, 2007Medtronic Inc. Cardiac Rhythm Managment
Vitatron C-Series C60DR DDDR Dual Chamber Rate Responsive Pacemaker includes the following models: C60A1 and C60A3. The Vitatron C60 DR is a dual chamber rate responsive pacemaker (activity sensing u
Terminated
NVZNone listed

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