KINETRA & SOLETRA FAMILY OF NEUROSTIMULATOR
FDA premarket approval P960009/S043 · decided 2008-01-11
Approval details
- PMA number
- P960009
- Supplement
- S043
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- KINETRA & SOLETRA FAMILY OF NEUROSTIMULATOR
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2007-09-17
- Decision date
- 2008-01-11
- Days to decision
- 116 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR CHANGING THE SURFACTANT USED TO HELP DISPERSE POLYTETRAFLUOROETHYLENE (PTFE) DURING THE BATTERY MANUFACTURING PROCESS.
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 |