FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Implanted Brain Stimulator For Epilepsy
PMA: P100026
·
Supplement: S001
·
Decision Dec 18, 2013
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
- S001
- Device Class
- FDA Class 3
- Product Code
- PFN
- Generic Name
- Implanted brain stimulator for epilepsy
- Medical Specialty
- Unknown
- Advisory Committee
- Neurology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- December 18, 2013
- Date Received
- November 18, 2013
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
ADDITION OF A SECONDARY COMPONENT SUPPLIER.
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 |