GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Conrolled Expansion
FDA premarket approval P040027/S075 · decided 2019-12-06
Approval details
- PMA number
- P040027
- Supplement
- S075
- 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 Conrolled Expansion
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2019-10-25
- Decision date
- 2019-12-06
- Days to decision
- 42 days
- Decision code
- OK30
- Product code
- MIR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Phonix, AZ
- Statement
- approval for alternate manufacturing equipment as well as the changes this equipment introduces into the stent winding and heat treatment process for the GORE VIATORR TIPS Endoprosthesis and the GORE VIATORR TIPS Endoprosthesis with Controlled Expansion
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