ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM
FDA premarket approval P960009/S230 · decided 2015-06-26
Approval details
- PMA number
- P960009
- Supplement
- S230
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2015-05-28
- Decision date
- 2015-06-26
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR CHANGES TO THE USER MANUAL FOR THE IMPLANTABLE NEUROSTIMULATOR RECHARGING SYSTEMS; SPECIFICALLY, THE ADDITION OF A WARNING STATEMENT FOR THE ANTENNA LOCATE FEATURE, AS WELL AS INSTRUCTIONS FOR EXITING THIS FEATURE, AND DIRECTIONS TO CONTACT MEDTRONIC IF THE PATIENT ENCOUNTERS ANY PROBLEMS.
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510(k) clearances by this applicant
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|---|---|---|
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| 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 |