GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion
FDA premarket approval P040027/S076 · decided 2019-12-18
Approval details
- PMA number
- P040027
- Supplement
- S076
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2019-11-18
- Decision date
- 2019-12-18
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MIR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Phonix, AZ
- Statement
- Modified manufacturing process for the laminated film used in manufacture of the GORE VIATORR TIPS Endoprosthesis and the GORE VIATORR TIPS Endoprosthesis with Controlled Expansion.
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