FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Valve, Pulmonary
PMA: P180002
·
Supplement: S003
·
Decision May 3, 2019
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- Valve, Pulmonary
- Trade Name
- The Pulmonx Zephyr Endobronchial Valve System (EBV)
- PMA Number
- P180002
- Supplement Number
- S003
- 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
- May 3, 2019
- Date Received
- July 30, 2018
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol
- Expedited Review
- N
Advisory Committee Statement
Approval for the Pulmonx Zephyr® Endobronchial Valves. These are implantable bronchial valves which are indicated for the bronchoscopic treatment of adult patients with hyperinflation associated with severe emphysema in regions of the lung that have little to no collateral ventilation.
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 |