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Device | Gore Viatorr Tips Endoprosthesis |
Generic Name | SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS |
Applicant | W. L. GORE & ASSOCIATES, INC. 32360 N NORTH VALLEY PARKWAY PHOENIX, AZ 85085 |
PMA Number | P040027 |
Supplement Number | S060 |
Date Received | 04/16/2018 |
Decision Date | 05/18/2018 |
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 Implementation of an alternate resin and updates to the specifications and sampling plan used in manufacture of the zipper fiber component of the GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion. |