WALLSTENT TIPS ENDOPROSTHESIS
FDA premarket approval P930031/S004 · decided 1997-04-15
Approval details
- PMA number
- P930031
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- WALLSTENT TIPS ENDOPROSTHESIS
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Applicant
- Boston Scientific Corp
- Date received
- 1996-10-15
- Decision date
- 1997-04-15
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- MIR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR AN ALTERNATIVE DELIVERY SYSTEM WHICH ALLOWS THE USER TO PARTIALLY DEPLOY AND THEN RECONSTRAIN THE STENT TO FACILITATE PLACEMENT.
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