FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Valve, Pulmonary
PMA: P180007
·
Supplement: S012
·
Decision Jun 27, 2024
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- Valve, Pulmonary
- Trade Name
- Spiration Valve System Deployment Catheter and Loader
- PMA Number
- P180007
- Supplement Number
- S012
- Device Class
- FDA Class 3
- Product Code
- NJK
- Generic Name
- Valve, pulmonary
- Medical Specialty
- Unknown
- Advisory Committee
- Anesthesiology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- June 27, 2024
- Date Received
- May 17, 2024
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
changes to the manufacturing process of the thermal traverser and operator interface revisions of the thermal traverser
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 |