The following data is part of a premarket notification filed by St. Jude Medical, Cardiac Rhythm Management Divisi with the FDA for Sjm Confirm Implantable Cardiac Monitor.
| Device ID | K122090 |
| 510k Number | K122090 |
| Device Name: | SJM CONFIRM IMPLANTABLE CARDIAC MONITOR |
| Classification | Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) |
| Applicant | ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 15900 VALLEY VIEW CT. Sylmar, CA 91342 |
| Contact | Plessy Paul |
| Correspondent | Plessy Paul ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 15900 VALLEY VIEW CT. Sylmar, CA 91342 |
| Product Code | MXC |
| Subsequent Product Code | DSH |
| Subsequent Product Code | DXH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-16 |
| Decision Date | 2012-11-15 |
| Summary: | summary |