FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Aortic Stent
PMA: P240003
·
Decision Aug 28, 2024
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Aortic Stent
- Trade Name
- Minima Stent System
- PMA Number
- P240003
- 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
- August 28, 2024
- Date Received
- March 1, 2024
- Expedited Review
- N
Advisory Committee Statement
The Minima Stent System is indicated for use in the treatment of native or acquired pulmonary artery stenoses or coarctation of the aorta in neonates, infants, and children at least 1.5 kg in weight.
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 |