SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM)
FDA 510(k) clearance K133481 · decided 2014-05-28
Clearance details
- K-number
- K133481
- Device name
- SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM)
- Applicant
- St. Jude Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-11-13
- Decision date
- 2014-05-28
- Days to decision
- 196 days
- Clearance type
- Traditional
- Product code
- MXC
- Device class
- 2
- Regulation number
- 870.2800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Assert-IQ™ Insertable Cardiac Monitor (K230286) | ABBOTT MEDICAL | 2023-05-17 |
| Jot Dx Insertable Cardiac Monitor (K212206) | Abbott (St. Jude Medical) | 2021-08-13 |
| Confirm Rx Insertable Cardiac Monitor (K202876) | Abbott (St. Jude Medical) | 2020-12-01 |
| Confirm Rx Insertable Cardiac Monitor (K202888) | Abbott (St. Jude Medical) | 2020-11-23 |
| myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) (K193310) | Abbott (St. Jude Medical) | 2020-03-17 |
| Confirm Rx Insertable Cardiac Monitor (K192593) | Abbott | 2019-10-18 |
| Confirm Rx Insertable Cardiac Monitor (K190295) | Abbott (St. Jude Medical) | 2019-04-10 |
| Confirm Rx Insertable Cardiac Monitor (K182981) | Abbott | 2019-03-29 |
| myMerlin(TM) Mobile Application Model APP1001 (K173232) | St Jude Medical | 2017-11-02 |
| Confirm Rx Insertable Cardiac Monitor (ICM) System (K163407) | St. Jude Medical, Inc. | 2017-09-29 |
| SJM CONFIRM (K122161) | St Jude Medical | 2012-11-28 |
| SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (K122090) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2012-11-15 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S094) | St. Jude Medical, Inc. | 2016-02-12 |
| SENSOLOG / DIALOG/ REGENCY FAMILY OF PACEMAKERS (P880006/S093) | St. Jude Medical, Inc. | 2015-08-27 |
| SESOLOG / DIALOG / REGENCY FAMILY OF PACEMAKERS (P880006/S092) | St. Jude Medical, Inc. | 2015-02-25 |
| SENSOLOG/ DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S089) | St. Jude Medical, Inc. | 2014-09-12 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S088) | St. Jude Medical, Inc. | 2014-05-29 |
| SENSOLOG/ DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S081) | St. Jude Medical, Inc. | 2014-04-10 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S085) | St. Jude Medical, Inc. | 2014-03-20 |
| SENSOLOG/DIALOG/ REGENCY FAMILY OF PACEMAKERS (P880006/S087) | St. Jude Medical, Inc. | 2014-02-26 |