WALLSTENT (TIPS,ILIAC,VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMS
FDA premarket approval P980033/S001 · decided 2002-01-10
Approval details
- PMA number
- P980033
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- WALLSTENT (TIPS,ILIAC,VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMS
- Generic name
- Stent, central venous
- Applicant
- Boston Scientific Corporation
- Date received
- 2001-12-20
- Decision date
- 2002-01-10
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- QKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- 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.
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