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Device | GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion |
Generic Name | SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS |
Applicant | W. L. GORE & ASSOCIATES, INC. 32360 N NORTH VALLEY PARKWAY PHOENIX, AZ 85085 |
PMA Number | P040027 |
Supplement Number | S076 |
Date Received | 11/18/2019 |
Decision Date | 12/18/2019 |
Product Code |
MIR |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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. |