FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Stent, Central Venous
PMA: P980033
·
Supplement: S043
·
Decision Aug 12, 2015
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Stent, Central Venous
- Trade Name
- WALLSTENT VENOUS ENDOPROSTHESIS
- PMA Number
- P980033
- Supplement Number
- S043
- Device Class
- FDA Class 3
- Product Code
- QKJ
- Generic Name
- Stent, central venous
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 12, 2015
- Date Received
- March 9, 2015
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A CHANGE IN DEVICE LABELING FROM MR SAFE TO MR CONDITIONAL.
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 |