FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Stent, Coronary
PMA: P020009
·
Supplement: S061
·
Decision May 11, 2010
Classifications
1
FEI Numbers
28
Registration Numbers
28
Basic Information
- Device Name
- Stent, Coronary
- Trade Name
- EXPRESS2 OTW CORONARY STENT SYSTEM
- PMA Number
- P020009
- Supplement Number
- S061
- Device Class
- FDA Class 3
- Product Code
- MAF
- Generic Name
- STENT, CORONARY
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- May 11, 2010
- Date Received
- March 8, 2010
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR MATERIAL AND SPECIFICATION CHANGES TO THE STRAIN RELIEF.
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 |
|---|---|---|---|
| MAF | Stent, Coronary | FDA class 3 | Unknown |