FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Implanted Brain Stimulator For Epilepsy
PMA: P100026
·
Supplement: S069
·
Decision Feb 20, 2020
Classifications
1
FEI Numbers
3
Registration Numbers
3
Basic Information
- Device Name
- Implanted Brain Stimulator For Epilepsy
- Trade Name
- NeuroPace RNS System
- PMA Number
- P100026
- Supplement Number
- S069
- Device Class
- FDA Class 3
- Product Code
- PFN
- Generic Name
- Implanted brain stimulator for epilepsy
- Medical Specialty
- Unknown
- Advisory Committee
- Neurology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- February 20, 2020
- Date Received
- May 31, 2019
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for the MRI Conditional labeling for the RNS system products.
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 |
|---|---|---|---|
| PFN | Implanted Brain Stimulator For Epilepsy | FDA class 3 | Unknown |