FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Aortic Stent
PMA: P150028
·
Supplement: S004
·
Decision Dec 19, 2019
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Aortic Stent
- Trade Name
- CP Stent, Covered CP Stent, Mounted CP Stent, Covered and Mounted CP Stent, Mounted CP Stent, NuDEL
- PMA Number
- P150028
- Supplement Number
- S004
- Device Class
- FDA Class 3
- Product Code
- PNF
- Generic Name
- Aortic stent
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- December 19, 2019
- Date Received
- November 26, 2019
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Addition of two laser welders.
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 |
|---|---|---|---|
| PNF | Aortic Stent | FDA class 3 | Unknown |