MODEL 3510 PROGRAMMER/3303 SOFTWARE
FDA premarket approval P830045/S064 · decided 1999-04-21
Approval details
- PMA number
- P830045
- Supplement
- S064
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 3510 PROGRAMMER/3303 SOFTWARE
- Generic name
- Programmer, pacemaker
- Applicant
- St. Jude Medical, Inc.
- Date received
- 1999-03-24
- Decision date
- 1999-04-21
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- KRG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for the Model 3510 Programmer with Model 3303 version 1.02 Software. The device, as modified, will be marketed under the trade name the Model 3510 Programmer with Model 3303 version 1.02 Software and is indicated for the programming and interrogation of implanted St. Jude Pacemakers.
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| 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 |