APS III PROGRAMMER WITH SOFTWARE MODEL 3302 REV.D (V1.04)
FDA premarket approval P830045/S061 · decided 1998-10-21
Approval details
- PMA number
- P830045
- Supplement
- S061
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- APS III PROGRAMMER WITH SOFTWARE MODEL 3302 REV.D (V1.04)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- St. Jude Medical, Inc.
- Date received
- 1998-09-11
- Decision date
- 1998-10-21
- Days to decision
- 40 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for the APS III Model 3500 Programmer Software Revision D (version 1.04).
Class III intelligence, same tools
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510(k) clearances by this applicant
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|---|---|---|
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| 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 |