FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Aortic Stent
PMA: P240003
·
Supplement: S001
·
Decision Nov 8, 2024
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Aortic Stent
- Trade Name
- Minima Stent System
- PMA Number
- P240003
- Supplement Number
- S001
- 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 8, 2024
- Date Received
- September 23, 2024
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol
- Expedited Review
- N
Advisory Committee Statement
Approval for the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P240003.
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 |