510(k) K163407 ยท MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
Confirm Rx Insertable Cardiac Monitor (ICM) System
| Applicant | St. Jude Medical, Inc., Sylmar CA, US |
| Decision | Substantially Equivalent, Sep 29, 2017 |
| Received | Dec 5, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163407
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 25, 2019 | Abbott 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 wire Terminated |
MXC | None listed |
| Apr 16, 2018 | St Jude Medical Inc. 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 Terminated |
MXC | None listed |
| Apr 16, 2018 | St Jude Medical Inc. 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 p Terminated |
MXC | 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.