FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
PMA: P140009
·
Supplement: S123
·
Decision Aug 29, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Stimulator, Electrical, Implanted, For Parkinsonian Tremor
- Trade Name
- Infinity Deep Brain Stimulation (DBS) IPG
- PMA Number
- P140009
- Supplement Number
- S123
- Device Class
- FDA Class 3
- Product Code
- MHY
- Generic Name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Medical Specialty
- Unknown
- Advisory Committee
- Neurology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- August 29, 2025
- Date Received
- August 1, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
approval for the addition of a fixture which will be utilized in the manufacturing process of the Proclaim SCS, Proclaim DRG and Infinity DBS Implantable Pulse Generators
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 |