MODEL 3510 PROGRAMMER AND MODEL 3134 EXTERNAL VIDEO CABLE
FDA premarket approval P830045/S089 · decided 2003-10-31
Approval details
- PMA number
- P830045
- Supplement
- S089
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 3510 PROGRAMMER AND MODEL 3134 EXTERNAL VIDEO CABLE
- Generic name
- Programmer, pacemaker
- Applicant
- St. Jude Medical, Inc.
- Date received
- 2003-10-07
- Decision date
- 2003-10-31
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- KRG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR MODIFICATION TO THE MODEL 3510 PROGRAMMER PLATFORM BY ADDING A VIDEO DISPLAY OUT PORT AND THE ADDITION OF A NEW VIDEO CABLE, MODEL 3134.
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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 |