FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Stimulator, Invasive Bone Growth
PMA: P850035
·
Supplement: S034
·
Decision Feb 27, 2012
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Stimulator, Invasive Bone Growth
- Trade Name
- SPF PLUS-MINI (60UA/W) AND SPF PLUS-MINI (60UA/M)
- PMA Number
- P850035
- Supplement Number
- S034
- 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
- February 27, 2012
- Date Received
- February 1, 2012
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
ADDITION OF AN ALTERNATE SUPPLIER OF COIN CELL BATTERIES.
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 |