FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Stent, Central Venous
PMA: P980033
·
Supplement: S013
·
Decision Oct 31, 2005
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Stent, Central Venous
- Trade Name
- WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (VENOUS)
- PMA Number
- P980033
- Supplement Number
- S013
- 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
- October 31, 2005
- Date Received
- March 14, 2005
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Express GMP Supplement
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC EUROPEAN DISTRIBUTION CENTER (EDC), KERKRADE, THE NETHERLANDS. THIS FACILITY WILL RELABEL AND PACKAGE VARIOUS STENTS AND PTCA CATHETERS.
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 |