FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation
PMA: P210007
·
Supplement: S004
·
Decision Jan 24, 2025
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation
- Trade Name
- MicroTransponder® Vivistim® Paired VNS System
- PMA Number
- P210007
- Supplement Number
- S004
- Device Class
- FDA Class 3
- Product Code
- QPY
- Generic Name
- Stimulator, autonomic nerve, implanted for stroke rehabilitation
- Medical Specialty
- Unknown
- Advisory Committee
- Physical Medicine
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- January 24, 2025
- Date Received
- January 15, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
undefined
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 |
|---|---|---|---|
| QPY | Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation | FDA class 3 | Unknown |