FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Stent, Central Venous
PMA: P980033
·
Supplement: S060
·
Decision Oct 14, 2022
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Stent, Central Venous
- Trade Name
- Venous Wallstent and Wallstent Venous Endoprosthesis with Unistep Plus Delivery System
- PMA Number
- P980033
- Supplement Number
- S060
- Device Class
- FDA Class 3
- Product Code
- QKJ
- Generic Name
- Stent, central venous
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- October 14, 2022
- Date Received
- September 14, 2022
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Addition of an alternative heat seal coating to be used on the packaging.
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 |
|---|---|---|---|
| QKJ | Stent, Central Venous | FDA class 3 | Unknown |