FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Stent, Iliac
PMA: P090003
·
Supplement: S051
·
Decision Apr 30, 2021
Classifications
1
FEI Numbers
34
Registration Numbers
34
Basic Information
- Device Name
- Stent, Iliac
- Trade Name
- Express LD Iliac Premounted Stent System
- PMA Number
- P090003
- Supplement Number
- S051
- Device Class
- FDA Class 3
- Product Code
- NIO
- Generic Name
- STENT, ILIAC
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- April 30, 2021
- Date Received
- March 1, 2021
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for the use of an alternate strain relief component of the delivery system Y-connector assembly.
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 |