FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Pulmonary Stent
PMA: P220004
·
Supplement: S001
·
Decision Nov 2, 2023
Classifications
1
FEI Numbers
2
Registration Numbers
2
Basic Information
- Device Name
- Pulmonary Stent
- Trade Name
- PALMAZ MULLINS XD Pulmonary Stent
- PMA Number
- P220004
- Supplement Number
- S001
- Device Class
- FDA Class 3
- Product Code
- QWC
- Generic Name
- Pulmonary stent
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 2, 2023
- Date Received
- September 19, 2023
- 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) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P220004.
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 |
|---|---|---|---|
| QWC | Pulmonary Stent | FDA class 3 | Unknown |