FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Stimulator, Invasive Bone Growth
PMA: P790008
·
Supplement: S003
·
Decision Aug 17, 1982
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Stimulator, Invasive Bone Growth
- Trade Name
- ZIMMER DIRECT CURRENT BONE GROWTH STIMULATOR
- PMA Number
- P790008
- Supplement Number
- S003
- Device Class
- FDA Class 3
- Product Code
- LOE
- Generic Name
- Stimulator, invasive bone growth
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 17, 1982
- Date Received
- July 29, 1982
- Supplement Type
- Normal 180 Day Track
- 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 |
|---|---|---|---|
| LOE | Stimulator, Invasive Bone Growth | FDA class 3 | Unknown |