FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Stent, Iliac
PMA: P020036
·
Supplement: S058
·
Decision Dec 4, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Stent, Iliac
- Trade Name
- S.M.A.R.T.® CONTROL® Nitinol Stent System
- PMA Number
- P020036
- Supplement Number
- S058
- 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
- December 4, 2025
- Date Received
- November 21, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
an alternate supplier for bismuth sub carbonate (BSC) for the catheter tip
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 |