510(k) Report

FDA applicant

Medtronic Cardiac Rhythm Disease Management

Mounds View8 decisions1979–200523 recalls

FDA records 8 decisions for Medtronic Cardiac Rhythm Disease Management (Mounds View) from 1979 to 2005: 8 original PMA approvals. Most are in product codes NVN (Drug Eluting Permanent Right Ventricular (Rv)…) and LWP (Implantable Pulse Generator, Pacemaker (Non-Crt)). 23 recalls are linked to its devices, 4 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Medtronic Cardiac Rhythm Disease Management’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medtronic Cardiac Rhythm Disease Management since 2007.

Recalls per year

2in 2025

2008: 32018: 62020: 32021: 6, 2 Class I2023: 2, 2 Class I2025: 2
2007high 6 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medtronic Cardiac Rhythm Disease Management by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medtronic Cardiac Rhythm Disease…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • NVNDrug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes3decisions
  • LWPImplantable Pulse Generator, Pacemaker (Non-Crt)2decisions
  • LWSImplantable Cardioverter Defibrillator (Non-Crt)2decisions
  • NIKDefibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)1decision

What has FDA decided for it lately?

  • P030036Medtronic Selectsecure Lead Model 3830Medtronic Cardiac Rhythm Disease Management · 2005
  • P010031Concerto/Insync Sentry/Insync Maximo Implantable Cardiovascular Defibrillators with Cardiac ResynchicnizationMedtronic Cardiac Rhythm Disease Management · 20021 Class I recall
  • P980016Virtuso/Entrust/Maximo/Intrinsic/Marquis/Implantable Cardiverter DefibrillatorsMedtronic Cardiac Rhythm Disease Management · 19983 Class I recalls
  • P900061Medtronic PCD Tachyarrhythmia Control SystemMedtronic Cardiac Rhythm Disease Management · 1993
  • P830061Steroid Tip (TM) Model 4503&4003 Transvenous PacingMedtronic Cardiac Rhythm Disease Management · 1986
  • P850089Capsure SP, Capsure, Capsure 2 Leads, Excellence S, Impulse, Impluse II Excellence SS, LeadsMedtronic Cardiac Rhythm Disease Management · 1986
  • P820003Versatrax Model 7000 Universal a-V Pulse GeneratorMedtronic Cardiac Rhythm Disease Management · 1982
  • P780009Byrel Programable PacemakerMedtronic Cardiac Rhythm Disease Management · 1979

All 8 as Medtronic Cardiac Rhythm Disease Management →

What has been recalled?

23 recalls linked to its devices; the latest:

  • P890003Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number…Jun 17, 2025Class II
  • P890003Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967…Jun 17, 2025Class II
  • P980016ICD-VR DVEX2E4 EV ICD OUS EV4, Model Number DVEX2E4; Implantable Cardioverter…May 10, 2023Class I
  • P980016ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; Implantable Cardioverter…May 10, 2023Class I
  • P010031CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to…Apr 6, 2021Class II
  • P010031Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used…Apr 6, 2021Class II