Confirm Rx Insertable Cardiac Monitor (ICM) System— 510(k) K163407

Clearance details

Applicant

St. Jude Medical, Inc.

Product code

Code MXC

Device class

Class 2

Regulation

21 CFR 870.2800

Advisory panel

Cardiovascular

Date received

2016-12-05

Decision date

2017-09-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Sylmar, CA, US

• K230286 — Assert-IQ Insertable Cardiac Monitor2023-05-17
• K212206 — Jot Dx Insertable Cardiac Monitor2021-08-13
• K202876 — Confirm Rx Insertable Cardiac Monitor2020-12-01
• K202888 — Confirm Rx Insertable Cardiac Monitor2020-11-23
• K193310 — myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)2020-03-17

• K172393 — Advisor HD Grid Mapping Catheter, Sensor Enabled2018-04-23
• K161171 — PressureWire X Guidewire2016-08-15
• K161102 — Nanostim Introducer Kit2016-05-19
• K160716 — The Nanostim Introducer Kit2016-04-14
• K140793 — NANOSTIM INTRODUCER KIT2014-12-17

Death

4

Injury

758

Malfunction

5,066

Total

5,828

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1220-2019 — St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network (PCN). It is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.Class II·Terminated·Abbott·20181119
• Z-2334-2018 — St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.Class II·Terminated·St Jude Medical Inc.·20180416
• Z-2335-2018 — Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, external device used to support the implanted device, and for this recall the software that resides on the programmer (software model 3330) is the method of delivery of the new firmware.Class II·Terminated·St Jude Medical Inc.·20180416
• Z-0808-2020 — Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.Class II·Terminated·St Jude Medical, Cardiac Rhythm Management Division·20180413

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K163407.