WALLSTENT TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
FDA premarket approval P930031/S012 · decided 2002-02-12
Approval details
- PMA number
- P930031
- Supplement
- S012
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- WALLSTENT TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Applicant
- Boston Scientific Corp
- Date received
- 2002-01-09
- Decision date
- 2002-02-12
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- MIR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE AND THE PACKAGE LABELING.
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