FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Valve, Pulmonary
PMA: P180002
·
Supplement: S011
·
Decision Dec 23, 2019
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- Valve, Pulmonary
- Trade Name
- Zephyr Endobronchial Valve System
- PMA Number
- P180002
- Supplement Number
- S011
- Device Class
- FDA Class 3
- Product Code
- NJK
- Generic Name
- Valve, pulmonary
- Medical Specialty
- Unknown
- Advisory Committee
- Anesthesiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 23, 2019
- Date Received
- September 30, 2019
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for including a smaller outer shipper box option which has the capacity for up to five (5) Zephyr Endobronchial Delivery Catheter (EDC) devices.
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 |
|---|---|---|---|
| NJK | Valve, Pulmonary | FDA class 3 | Unknown |