MEDTRONIC MODEL 2090 BURBOT AND SPLAKE PROGRAMMERS
FDA premarket approval P890003/S120 · decided 2007-06-07
Approval details
- PMA number
- P890003
- Supplement
- S120
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC MODEL 2090 BURBOT AND SPLAKE PROGRAMMERS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2007-05-14
- Decision date
- 2007-06-07
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR AN ALTERNATE HARD DISK DRIVE (HDD) USED ON MEDTRONIC MODEL 2090 ?BURBOT? THAT ALSO INCLUDES A MINOR DESIGN CHANGE AND AN ALTERNATE FLOPPY DISC DRIVE (FDD) USED ON BOTH MEDTRONIC MODEL 2090 ?SPLAKE? AND ?BURBOT? CARELINK PROGRAMMERS.
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 |
|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
| Concerto Versa™ Detachable Coil (K261866) | Medtronic, Inc. | 2026-06-24 |
| Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae (K260195) | Medtronic, Inc. | 2026-04-23 |
| Retrograde Coronary Sinus Perfusion Cannulae (K253203) | Medtronic, Inc. | 2026-02-19 |
| Clearview Intracoronary Shunts (K253998) | Medtronic, Inc. | 2026-01-20 |
| Bio-Medicus Life Support Catheter and Introducer (K251831) | Medtronic, Inc. | 2026-01-15 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
| C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409) | Medtronic, Inc. | 2025-12-19 |