Company
St. Jude Medical, Cardiac Rhythm Management Division
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
14recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LWS | Implantable Cardioverter Defibrillator (Non-Crt) | 5 |
| DXY | Implantable Pacemaker Pulse-Generator | 3 |
| NVZ | Pulse Generator, Permanent, Implantable | 3 |
| MXC | Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) | 1 |
| NIK | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | 1 |
| OSR | Pacemaker/Icd/Crt Non-Implanted Components | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 17, 2022 | St. Jude Medical, Cardiac Rhythm Management Division Merlin.net model MN5000 Software Open, Classified |
DXY | None listed |
| Jun 17, 2022 | St. Jude Medical, Cardiac Rhythm Management Division Merlin 2 PCS MER37000 programmer Model MER3400 software Open, Classified |
DXY | None listed |
| Jun 17, 2022 | St. Jude Medical, Cardiac Rhythm Management Division Merlin PCS 3650 programmer Model 3330 software Open, Classified |
DXY | None listed |
| Mar 10, 2022 | St. Jude Medical, Cardiac Rhythm Management Division Gallant HF Implantable Cardioverter Defibrillator
REF# CDHFA500Q Open, Classified |
LWS | None listed |
| Mar 10, 2022 | St. Jude Medical, Cardiac Rhythm Management Division Gallant VR Implantable Cardioverter Defibrillator
REF # CDVRA500Q Open, Classified |
LWS | None listed |
| Mar 10, 2022 | St. Jude Medical, Cardiac Rhythm Management Division Gallant DR Implantable Cardioverter Defibrillator
REF # CDDRA500Q Open, Classified |
LWS | None listed |
| Mar 10, 2022 | St. Jude Medical, Cardiac Rhythm Management Division Merlin 2 PCS MER3700 programmer Model MER3400 software Open, Classified |
NIK | None listed |
| Mar 10, 2022 | St. Jude Medical, Cardiac Rhythm Management Division Merlin PCS 3650 programmer Model 3330 software Open, Classified |
OSR | 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 |
| Apr 13, 2018 | St Jude Medical, Cardiac Rhythm Management Division 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 Manag Terminated |
MXC | K163407 |
| Jan 21, 2016 | St Jude Medical Cardiac Rhythm Management Division Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrilla Terminated |
LWS | 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 |
| Sep 3, 2014 | St Jude Medical Cardiac Rhythm Management Division Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411
Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, Terminated |
LWS | None listed |