FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Stimulator, Invasive Bone Growth
PMA: P790005
·
Supplement: S063
·
Decision May 4, 2018
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Stimulator, Invasive Bone Growth
- Trade Name
- EBI OsteoGen Impantable Bone Growth Stimulators
- PMA Number
- P790005
- Supplement Number
- S063
- Device Class
- FDA Class 3
- Product Code
- LOE
- Generic Name
- Stimulator, invasive bone growth
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- May 4, 2018
- Date Received
- April 4, 2018
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Modifying and upgrading the Compressed Contact Air Utility System to replace the existing, legacy, compressed contact air system to conform to the company's newly adopted global engineering specification.
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 |