FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Aortic Stent
PMA: P150028
·
Supplement: S002
·
Decision Nov 14, 2018
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Aortic Stent
- Trade Name
- NuDel Delivery System
- PMA Number
- P150028
- Supplement Number
- S002
- Device Class
- FDA Class 3
- Product Code
- PNF
- Generic Name
- Aortic stent
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 14, 2018
- Date Received
- March 7, 2018
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for the NuDEL Delivery 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 |
|---|---|---|---|
| PNF | Aortic Stent | FDA class 3 | Unknown |