FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Stent, Iliac
PMA: P020036
·
Supplement: S057
·
Decision Sep 12, 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
- S057
- 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
- September 12, 2025
- Date Received
- August 26, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
an additional supplier of the packaging tray and minor geometry modifications
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 |