FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Stent, Central Venous
PMA: P980033
·
Supplement: S001
·
Decision Jan 10, 2002
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Stent, Central Venous
- Trade Name
- WALLSTENT (TIPS,ILIAC,VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMS
- PMA Number
- P980033
- Supplement Number
- S001
- 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
- January 10, 2002
- Date Received
- December 20, 2001
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Express GMP Supplement
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT BOSTON SCIENTIFIC IRELAND LTD. (BSIL), GALWAY, IRELAND AND AN ALTERNATE STERILIZATION FACILITY LOCATED AT ISOTRON, OFFALY, IRELAND.
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 |