AURORA/QUADRA, REFLEX, SIMPLEX,META PACEMAKERS
FDA premarket approval P820018/S074 · decided 2006-03-14
Approval details
- PMA number
- P820018
- Supplement
- S074
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AURORA/QUADRA, REFLEX, SIMPLEX,META PACEMAKERS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- St. Jude Medical, Inc.
- Date received
- 2006-01-25
- Decision date
- 2006-03-14
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE EPIC II/EPIC II+ AND EPIC II HF DEVICES. THE MODIFICATIONS INCLUDE ADDING A VIBRATORY PATIENT NOTIFIER; MODIFYING THE ELECTROGRAM MORPHOLOGY ALGORITHM; MODIFYING THE CAPACITOR MAINTENANCE FEATURE; CHANGING THE MATERIALS OF THE CAN AND HEADER; AND MINOR CHANGES TO PACKAGING AND SOFTWARE. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES EPIC II/EPIC II+ DR/VR/HF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS (MODELS V-158, V-255, V-258, AND V-355)
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Advisor HD Grid Mapping Catheter, Sensor Enabled (K172393) | St. Jude Medical, Inc. | 2018-04-23 |
| Confirm Rx Insertable Cardiac Monitor (ICM) System (K163407) | St. Jude Medical, Inc. | 2017-09-29 |
| PressureWire X Guidewire (K161171) | St. Jude Medical, Inc. | 2016-08-15 |
| Nanostim Introducer Kit (K161102) | St. Jude Medical, Inc. | 2016-05-19 |
| The Nanostim Introducer Kit (K160716) | St. Jude Medical, Inc. | 2016-04-14 |
| NANOSTIM INTRODUCER KIT (K140793) | St. Jude Medical, Inc. | 2014-12-17 |
| SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) (K133481) | St. Jude Medical, Inc. | 2014-05-28 |
| ENLIGHTN RENAL GUIDE CATHETER (K131592) | St. Jude Medical, Inc. | 2014-01-31 |