FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Stent, Coronary
PMA: P810046
·
Supplement: S232
·
Decision Feb 4, 2010
Classifications
1
FEI Numbers
28
Registration Numbers
28
Basic Information
- Device Name
- Stent, Coronary
- Trade Name
- VOYAGER NC CORONARY DILATATION CATHETER
- PMA Number
- P810046
- Supplement Number
- S232
- 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
- February 4, 2010
- Date Received
- December 9, 2009
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A LINE EXTENSION FOR A 1.5MM DIAMETER SIZE OF THE VOYAGER NC CORONARY DILATION CATHETER.
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 |