The following data is part of a premarket notification filed by St. Jude Medical, Inc. with the FDA for Confirm Rx Insertable Cardiac Monitor (icm) System.
| Device ID | K163407 |
| 510k Number | K163407 |
| Device Name: | Confirm Rx Insertable Cardiac Monitor (ICM) System |
| Classification | Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) |
| Applicant | St. Jude Medical, Inc. 15900 Valley View Ct. Sylmar, CA 91342 |
| Contact | Jennifer Dunham |
| Correspondent | Jennifer Dunham St. Jude Medical, Inc. 15900 Valley View Ct. Sylmar, CA 91342 |
| Product Code | MXC |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-05 |
| Decision Date | 2017-09-29 |
| Summary: | summary |