Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Basic Information
- Device Name
- Stimulator, Electrical, Implanted, For Parkinsonian Tremor
- Trade Name
- Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense
- PMA Number
- P960009
- Supplement Number
- S422
- Device Class
- FDA Class 3
- Product Code
- MHY
- Generic Name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Medical Specialty
- Unknown
- Advisory Committee
- Neurology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 25, 2022
- Date Received
- February 24, 2022
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol
- Expedited Review
- N
Advisory Committee Statement
Approval of the following revisions to the protocol for the post-approval study (PAS), DBS for Epilepsy New Enrollment PAS: a) evaluate seizure worsening and changes in seizure frequency over time without formal hypothesis testing for safety; b) change the sample size for the primary effectiveness objective to approximately 72 evaluable subjects at 3 years (140 enrolled subjects to have 90 implanted subjects) from 112 evaluable subjects at 3 years (216 enrolled subjects to have 140 implanted subjects); c) change in baseline diary length from 84 days to 28 days; d) update to estimated study milestones; e) migration to a new Medtronic Clinical Investigation Plan (CIP) template; and f) general clerical edits (e.g., addition of lead Principal Investigator name and contact information, formatting, grammar/wording for consistency, improved readability, etc.).
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MHY | Stimulator, Electrical, Implanted, For Parkinsonian Tremor | FDA class 3 | Unknown |