FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Aortic Stent
PMA: P240003
·
Supplement: S005
·
Decision Dec 18, 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
- S005
- Device Class
- FDA Class 3
- Product Code
- PNF
- Generic Name
- Aortic stent
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- December 18, 2025
- Date Received
- September 30, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
to move the dimensional inspection of the Minima Stent from a receiving step at the system assembly contract manufacturer, Medical Murray, to an outgoing inspection at the Minima Stent Manufacturer, Meko Laser
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 |