|
Device | GORE VIATORR TIPSEndoprosthesis product family |
Generic Name | SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS |
Applicant | W. L. GORE & ASSOCIATES, INC. 32360 N NORTH VALLEY PARKWAY PHOENIX, AZ 85085 |
PMA Number | P040027 |
Supplement Number | S074 |
Date Received | 09/03/2019 |
Decision Date | 02/28/2020 |
Product Code |
MIR |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of a new ethylene oxide sterilization cycle to pe performed at a new sterilization site (Sterigenics US, LLC located at 4900 Gifford Ave. Los Angeles, CA). |