ACTIVA TREMOR CONTROL THERAPY SYSTEM
FDA premarket approval P960009/S020 · decided 2001-08-10
Approval details
- PMA number
- P960009
- Supplement
- S020
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACTIVA TREMOR CONTROL THERAPY SYSTEM
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2001-07-10
- Decision date
- 2001-08-10
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE ADDITION OF AN ADDITIONAL QUALITY CONTOROL PROCESS STEP TO VERIFY THAT NEUROSTIMULATORS ARE MANUFACTURED TO THEIR SPECIFICATION, E.G., THE NEUROSTIMULATOR HAS THE SPECIFIED INSULATION BETWEEN THE BATTERY AND THE INTERNAL SURFACE OF THE TITANIUM CASE (SHIELD).
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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 |