REGENCY SC+, REGENCY SC, REGENCY SCX
FDA premarket approval P880006/S029 · decided 2000-01-28
Approval details
- PMA number
- P880006
- Supplement
- S029
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- REGENCY SC+, REGENCY SC, REGENCY SCX
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- St. Jude Medical, Inc.
- Date received
- 1999-07-22
- Decision date
- 2000-01-28
- Days to decision
- 190 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval is for the Model 3304 Programmer Software for use with the Model 3500 and Model 3510 Programmers. The device is indicated for the programming and interrogation of implanted St. Jude pacemakers.
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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 |