FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Iliac Covered Stent, Arterial
PMA: P160021
·
Supplement: S052
·
Decision Jun 16, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Iliac Covered Stent, Arterial
- Trade Name
- GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
- PMA Number
- P160021
- Supplement Number
- S052
- Device Class
- FDA Class 3
- Product Code
- PRL
- Generic Name
- Iliac covered stent, arterial
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- June 16, 2026
- Date Received
- May 22, 2026
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
approval of an updated controller within the stent crimper 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 |
|---|---|---|---|
| PRL | Iliac Covered Stent, Arterial | FDA class 3 | Unknown |