VITATRON
FDA premarket approval P990001/S028 · decided 2007-07-10
Approval details
- PMA number
- P990001
- Supplement
- S028
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VITATRON
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2007-02-26
- Decision date
- 2007-07-10
- Days to decision
- 134 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE VITATRON FAMILY APPLICATION SOFTWARE MODELS THAT SUPPORT THE DIVA, DEMA AND SELECTION AFM 902 DEVICES (VSC02 VERSION 9.1 SR1), C-SERIES DEVICES A1 MODELS (VSF04 VERSION 1.3), C-SERIES DEVICES A3 MODELS (VSF12 VERSION 1.2, AND T-SERIES DEVICES (VSF08 VERSION 1.6). THE MODIFICATIONS WILL UPDATE THE EMI BEHAVIOR OF YOUR DEVICE, CORRECT THE ISSUE OF DA+ INHIBITION OF PACING BELOW THE PROGRAMMED THRESHOLD, IDENTIFY TO THE USER INACCURATE COULOMB COUNTS, ALLOW THE APP
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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 |