FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Stent, Superficial Femoral Artery, Drug-Eluting
PMA: P180011
·
Supplement: S002
·
Decision Dec 14, 2018
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Stent, Superficial Femoral Artery, Drug-Eluting
- Trade Name
- Eluvia Drug-Eluting Vascular Stent System
- PMA Number
- P180011
- Supplement Number
- S002
- Device Class
- FDA Class 3
- Product Code
- NIU
- Generic Name
- Stent, superficial femoral artery, drug-eluting
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- December 14, 2018
- Date Received
- November 14, 2018
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Change to parameters associated with the stent laser cutting process.
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 |
|---|---|---|---|
| NIU | Stent, Superficial Femoral Artery, Drug-Eluting | FDA class 3 | Unknown |