WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
FDA premarket approval P980033/S008 · decided 2003-12-11
Approval details
- PMA number
- P980033
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
- Generic name
- Stent, central venous
- Applicant
- Boston Scientific Corporation
- Date received
- 2003-11-17
- Decision date
- 2003-12-11
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- QKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR THE ADDITION OF TWO MANUFACTURING FACILITIES LOCATED AT BOSTON SCIENTIFIC CORP., QUINCY, MASSACHUSETTS AND BOSTON SCIENTIFIC EUROPEAN DISTRIBUTION CENTER, MAASTRICHT-AIRPORT, THE NETHERLANDS. THESE FACILITIES WILL PERFORM PACKAGING AND LABELING OPERATIONS FOR THE WALLSTENT ENDOPROSTHESIS WITH THE UNISTEP PLUS DELIVERY SYSTEM.
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