FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis
PMA: P000057
·
Supplement: S012
·
Decision Mar 20, 2024
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis
- Trade Name
- Ascension MCP
- PMA Number
- P000057
- Supplement Number
- S012
- Device Class
- FDA Class 3
- Product Code
- NEG
- Generic Name
- Finger semi-constrained pyrolytic carbon uncemented prosthesis
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 20, 2024
- Date Received
- January 5, 2024
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval to add MR Conditional labeling
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 |
|---|---|---|---|
| NEG | Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis | FDA class 3 | Unknown |