FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Stimulator, Invasive Bone Growth
PMA: P850035
·
Supplement: S024
·
Decision Apr 7, 1999
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Stimulator, Invasive Bone Growth
- Trade Name
- EBI SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR
- PMA Number
- P850035
- Supplement Number
- S024
- 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
- April 7, 1999
- Date Received
- July 6, 1998
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for labeling changes stating the device was MR Safe.
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 |