WALLSTENT(R) TIPS ENDOPROSTHESIS
FDA premarket approval P930031/S003 · decided 1997-01-03
Approval details
- PMA number
- P930031
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- WALLSTENT(R) TIPS ENDOPROSTHESIS
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Applicant
- Boston Scientific Corp
- Date received
- 1996-05-13
- Decision date
- 1997-01-03
- Days to decision
- 235 days
- Decision code
- APPR
- Product code
- MIR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR MODIFYING THE WIRE DIAMETER AND NUMBER OF WIRES IN THE 12 MM DIAMETER STENT, AND CORRECTS THE ACTUAL LENGTH TO BE MARKETED.
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