FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Stent, Carotid
PMA: P240009
·
Supplement: S007
·
Decision Jan 28, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Stent, Carotid
- Trade Name
- Neuroguard IEP® 3-in-1 Carotid Stent and Post- Dilatation Balloon System with Integrated Embolic Protection
- PMA Number
- P240009
- Supplement Number
- S007
- 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
- January 28, 2026
- Date Received
- December 18, 2025
- Supplement Type
- 135 Review Track For 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
removal of destructive testing at product release, updated in-process monitoring, and the addition of a pneumatic hypotube crimper for wire attachment
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 |