FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Stent, Coronary
PMA: P160014
·
Supplement: S012
·
Decision Dec 6, 2019
Classifications
1
FEI Numbers
28
Registration Numbers
28
Basic Information
- Device Name
- Stent, Coronary
- Trade Name
- COBRA PzF NanoCoated Coronary Stent System
- PMA Number
- P160014
- Supplement Number
- S012
- 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
- December 6, 2019
- Date Received
- July 19, 2019
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for a change in the bonding method of the hypotube bond.
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 |