FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Ligaments And Tendons, Synthetic
PMA: P850069
·
Supplement: S005
·
Decision Mar 8, 1990
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Ligaments And Tendons, Synthetic
- Trade Name
- KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE
- PMA Number
- P850069
- Supplement Number
- S005
- Device Class
- FDA Class 3
- Product Code
- LML
- Generic Name
- LIGAMENTS AND TENDONS, SYNTHETIC
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 8, 1990
- Date Received
- December 13, 1989
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- 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 |
|---|---|---|---|
| LML | Ligaments And Tendons, Synthetic | FDA class 3 | Unknown |