Percept and Activa Deep Brain Stimulation Therapy Systems
FDA premarket approval P960009/S385 · decided 2021-06-09
Approval details
- PMA number
- P960009
- Supplement
- S385
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Percept and Activa Deep Brain Stimulation Therapy Systems
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2020-09-04
- Decision date
- 2021-06-09
- Days to decision
- 278 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for 1) the Pain PC System for Spinal Cord Stimulation (SCS) which includes Implantable Neurostimulation Systems Vanta with AdaptiveStim and Sequentia LT; and 2) modified labeling for the Model B31060 Connector Plug to reflect its intended use with the Pain PC system.3) labeling updates for previously approved devices to be consistent with Pain PC system labeling.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
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| Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae (K260195) | Medtronic, Inc. | 2026-04-23 |
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| 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 |