FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Aortic Stent
PMA: P150028
·
Supplement: S005
·
Decision Jul 28, 2021
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Aortic Stent
- Trade Name
- NuDEL Delivery System
- PMA Number
- P150028
- Supplement Number
- S005
- 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
- July 28, 2021
- Date Received
- April 28, 2021
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval to extend the packaging shelf life of 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 |