SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR
FDA 510(k) clearance K081365 · decided 2008-08-15
Clearance details
- K-number
- K081365
- Device name
- SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR
- Applicant
- St Jude Medical
- Decision
- Substantially Equivalent
- Date received
- 2008-05-15
- Decision date
- 2008-08-15
- Days to decision
- 92 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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| Record | Firm | Date |
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| 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 |
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| 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 IMPLANTABLE CARDIAC MONITOR (ICM) (K133481) | St. Jude Medical, Inc. | 2014-05-28 |
| SJM CONFIRM (K122161) | St Jude Medical | 2012-11-28 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE). This product recall (Z-2733-2011) | St Jude Medical CRMD | 2011-07-05 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TactiSys Quartz Equipment; Ampere Generator (P130026/S102) | St Jude Medical | 2026-08-07 |
| Ampere Generator (P960016/S094) | St Jude Medical | 2026-08-07 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S100) | St Jude Medical | 2026-06-05 |
| TactiCath Ablation Catheter, Sensor Enabled (TactiCath SE) (P130026/S101) | St Jude Medical | 2026-05-29 |
| TactiCath CF Ablation Catheter, Sensor Enabled (A-TCSE-D; A-TCSE-F; A-TCSE-J; A-TCSE-DD; A-TCSE-DF; A-TCSE-FF; A-TCSE- (P130026/S099) | St Jude Medical | 2026-05-15 |
| TactiCath Sensor Enabled (P130026/S098) | St Jude Medical | 2026-01-15 |
| Livewire TC XLS (P960016/S093) | St Jude Medical | 2026-01-15 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (TactiCath SE) (P130026/S097) | St Jude Medical | 2026-01-08 |