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)
Top companies in NVZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | 0 | 16 |
| Medtronic Inc. | 0 | 7 |
| Medtronic Inc. Cardiac Rhythm Disease Managment | 0 | 5 |
| Medtronic Inc., Cardiac Rhythm and Heart Failure | 0 | 4 |
| St Jude Medical Cardiac Rhythm Management Division | 0 | 3 |
| Abbott Medical | 0 | 2 |
| Medtronic Inc. Cardiac Rhythm Managment | 0 | 2 |
| St. Jude Medical, Cardian Rhythm Management Division | 0 | 2 |
| ela Medical Llc | 0 | 1 |
| Medtronic Inc. Cardiac Rhythm Disease Management | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 27, 2026 | Medtronic, Inc. CareLink SmartSync Device Manager App, Model M01A02, Pulse generator, permanent, implantable Open, Classified |
NVZ | None listed |
| Oct 27, 2026 | Medtronic, Inc. CareLink SmartSync, RF Head Patient Connector, Model 24967, Pulse generator, permanent, implantable Open, Classified |
NVZ | None listed |
| Oct 27, 2026 | Medtronic, Inc. CareLink SmartSync Programmer, Model 24970A, Pulse generator, permanent, implantable Open, Classified |
NVZ | None listed |
| Jul 23, 2025 | Medtronic, 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 |
NVZ | None listed |
| Jul 23, 2025 | Medtronic, 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 |
NVZ | None listed |
| Jun 6, 2025 | Medtronic, Inc. Azure S DR MRI SureScan, Product number W3DR01 Open, Classified |
NVZ | None listed |
| Nov 26, 2024 | Abbott 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 |
NVZ | None listed |
| Nov 26, 2024 | Abbott 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 |
NVZ | None listed |
| Sep 13, 2024 | Medtronic 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 |
NVZ | None listed |
| Nov 8, 2021 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator Terminated |
NVZ | None listed |
| May 7, 2021 | St. 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 |
NVZ | None listed |
| May 7, 2021 | St. 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 |
NVZ | None listed |
| Jul 10, 2020 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06 Open, Classified |
NVZ | None listed |
| Jul 10, 2020 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05 Open, Classified |
NVZ | None listed |
| Jul 10, 2020 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04 Open, Classified |
NVZ | None listed |
| Jul 10, 2020 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Azure S SR MRI, Model Number W3SR01 Open, Classified |
NVZ | None listed |
| Jul 10, 2020 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01 Open, Classified |
NVZ | None listed |
| Jul 10, 2020 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Azure S DR MRI, Model Number W3DR01 Open, Classified |
NVZ | None listed |
| Jul 10, 2020 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01 Open, Classified |
NVZ | None listed |
| Jul 10, 2020 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Patient Connector, Model Number 24967 Open, Classified |
NVZ | None listed |
| Jan 22, 2020 | St 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 |
NVZ | None listed |
| Feb 14, 2019 | Medtronic 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 |
NVZ | None listed |
| Feb 14, 2019 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01 Open, Classified |
NVZ | None listed |
| Feb 14, 2019 | Medtronic 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 |
NVZ | None listed |
| Feb 14, 2019 | Medtronic 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 |
NVZ | None listed |
| Feb 14, 2019 | Medtronic 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 |
NVZ | None listed |
| Feb 14, 2019 | Medtronic 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 |
NVZ | None listed |
| Feb 14, 2019 | Medtronic 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 |
NVZ | None listed |
| Jul 14, 2017 | Medtronic 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 |
NVZ | None listed |
| Jul 14, 2017 | Medtronic 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 |
NVZ | None listed |
| Jul 5, 2016 | Medtronic 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 |
NVZ | None listed |
| Mar 31, 2016 | Medtronic 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 |
NVZ | None listed |
| Sep 28, 2015 | St 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 |
NVZ | None listed |
| Jan 9, 2015 | St 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 |
NVZ | None listed |
| Apr 29, 2011 | Medtronic 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 |
NVZ | None listed |
| Aug 11, 2010 | Medtronic 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 |
NVZ | None listed |
| Sep 24, 2009 | ela 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 |
NVZ | None listed |
| Jun 11, 2009 | Medtronic 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 |
NVZ | None listed |
| Jun 11, 2009 | Medtronic 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 |
NVZ | None listed |
| Jun 11, 2009 | Medtronic Inc. Cardiac Rhythm Disease Managment Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber Pacemaker, models KD701, KD703, and KD706. Terminated |
NVZ | None listed |
| Jun 11, 2009 | Medtronic 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 |
NVZ | None listed |
| Jul 7, 2007 | Medtronic 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 |
NVZ | None listed |
| Jul 7, 2007 | Medtronic 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 |
NVZ | None listed |
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