PMA P960009S383
- Device
- Activa Deep Brain Stimulation Therapy System and Percept PC Deep Brain Stimulation Therapy System
- Applicant
- Medtronic, Inc.
- Product code
- MHY
- Decision date
- 2020-10-28
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Activa Deep Brain Stimulation Therapy System and Percept PC Deep Brain Stimulation Therapy System
- Applicant
- Medtronic, Inc.
- PMA number
- P960009
- Supplement
- S383
- Product code
- MHY
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Decision date
- 2020-10-28
- Decision code
- APPR
- Date received
- 2020-09-02
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.