The following data is part of a premarket notification filed by St. Jude Medical, Inc. with the FDA for Sjm Confirm Implantable Cardiac Monitor (icm).
| Device ID | K133481 |
| 510k Number | K133481 |
| Device Name: | SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) |
| Classification | Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) |
| Applicant | ST. JUDE MEDICAL, INC. 645 ALMANOR AVENUE Sunnyvale, CA 94085 -2927 |
| Contact | Michael Mcsweeney |
| Correspondent | Michael Mcsweeney ST. JUDE MEDICAL, INC. 645 ALMANOR AVENUE Sunnyvale, CA 94085 -2927 |
| Product Code | MXC |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-13 |
| Decision Date | 2014-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734502573 | K133481 | 000 |