FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Stimulator, Functional Neuromuscular, Scoliosis
PMA: P820008
·
Supplement: S005
·
Decision Apr 2, 1987
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Stimulator, Functional Neuromuscular, Scoliosis
- Trade Name
- SCOLITRON(TM) STIMULATOR
- PMA Number
- P820008
- Supplement Number
- S005
- Device Class
- FDA Class 3
- Product Code
- LWB
- Generic Name
- Stimulator, functional neuromuscular, scoliosis
- Medical Specialty
- Unknown
- Advisory Committee
- Physical Medicine
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- April 2, 1987
- Date Received
- January 16, 1987
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
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 |
|---|---|---|---|
| LWB | Stimulator, Functional Neuromuscular, Scoliosis | FDA class 3 | Unknown |