FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Valve, Pulmonary
PMA: P180007
·
Supplement: S003
·
Decision May 21, 2019
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- Valve, Pulmonary
- Trade Name
- Spiration Valve System
- PMA Number
- P180007
- 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 21, 2019
- Date Received
- December 26, 2018
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol
- Expedited Review
- N
Advisory Committee Statement
Approval of the protocol for the post-approval study (PAS) protocol.
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 |