FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Stent, Carotid
PMA: P040038
·
Supplement: S045
·
Decision Jul 15, 2024
Classifications
1
FEI Numbers
24
Registration Numbers
24
Basic Information
- Device Name
- Stent, Carotid
- Trade Name
- XACT Transcarotid Stent System (XACT TSS)
- PMA Number
- P040038
- Supplement Number
- S045
- Device Class
- FDA Class 3
- Product Code
- NIM
- Generic Name
- Stent, carotid
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- July 15, 2024
- Date Received
- April 29, 2024
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for a shortened delivery system to be used in transcarotid stenting procedures
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 |
|---|---|---|---|
| NIM | Stent, Carotid | FDA class 3 | Unknown |