APSU PROGRAMMER, APSU SOFTWARE, BASE STATION
FDA premarket approval P830045/S057 · decided 1998-07-14
Approval details
- PMA number
- P830045
- Supplement
- S057
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- APSU PROGRAMMER, APSU SOFTWARE, BASE STATION
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- St. Jude Medical, Inc.
- Date received
- 1998-06-12
- Decision date
- 1998-07-14
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- approval for software modifications to the APS III Programmer Software Model 3302 Revision B (Paragon Version 1.02) resulting in APS III Programmer software Model 3302 Revision C (Paragon Version 1.03).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |