FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Stent, Superficial Femoral Artery
PMA: P110023
·
Supplement: S061
·
Decision Nov 7, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Stent, Superficial Femoral Artery
- Trade Name
- EverFlex self-expanding Peripheral Stent System (EverFlex)
- PMA Number
- P110023
- Supplement Number
- S061
- Device Class
- FDA Class 3
- Product Code
- NIP
- Generic Name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 7, 2025
- Date Received
- August 14, 2025
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for an alternate modified stopcock from the supplier for the EverFlex self-expanding Peripheral Stent System and Protégé GPS Self-Expanding Peripheral Stent System.
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 |
|---|---|---|---|
| NIP | Stent, Superficial Femoral Artery | FDA class 3 | Unknown |