Activa Deep Brain Stimulation Therapy System and Percept PC Deep Brain Stimulation Therapy System
FDA premarket approval P960009/S383 · decided 2020-10-28
Approval details
- PMA number
- P960009
- Supplement
- S383
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Activa Deep Brain Stimulation Therapy System and Percept PC Deep Brain Stimulation Therapy System
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2020-09-02
- Decision date
- 2020-10-28
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
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