GORE VIATORR TIPS
FDA premarket approval P040027/S048 · decided 2016-08-18
Approval details
- PMA number
- P040027
- Supplement
- S048
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GORE VIATORR TIPS
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2016-02-22
- Decision date
- 2016-08-18
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- MIR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Phonix, AZ
- Statement
- Approval for addition of GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion to the GORE® VIATORR® TIPS Endoprosthesis product line.
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