FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Aortic Stent
PMA: P240003
·
Supplement: S004
·
Decision Sep 11, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Aortic Stent
- Trade Name
- Minima Stent System
- PMA Number
- P240003
- Supplement Number
- S004
- 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
- September 11, 2025
- Date Received
- August 13, 2025
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for updates to the Instructions for Use labeling, including additional precautions, intended to enhance the safe use of the Minima Stent 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 |