FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Stimulator, Bone Growth, Non-Invasive
PMA: P790002
·
Supplement: S002
·
Decision Aug 20, 1982
Classifications
1
FEI Numbers
17
Registration Numbers
17
Basic Information
- Device Name
- Stimulator, Bone Growth, Non-Invasive
- Trade Name
- BIO OSTEOGEN SYSTEM 204
- PMA Number
- P790002
- Supplement Number
- S002
- Device Class
- FDA Class 3
- Product Code
- LOF
- Generic Name
- Stimulator, bone growth, non-invasive
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 20, 1982
- Date Received
- July 15, 1982
- 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 |
|---|---|---|---|
| LOF | Stimulator, Bone Growth, Non-Invasive | FDA class 3 | Unknown |