FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Stent, Iliac
PMA: P110035
·
Supplement: S074
·
Decision Aug 8, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Stent, Iliac
- Trade Name
- Epic Vascular Self-Expanding Stent System
- PMA Number
- P110035
- Supplement Number
- S074
- Device Class
- FDA Class 3
- Product Code
- NIO
- Generic Name
- STENT, ILIAC
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- August 8, 2025
- Date Received
- July 22, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
an alternate supplier of a delivery system component
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 |
|---|---|---|---|
| NIO | Stent, Iliac | FDA class 3 | Unknown |