|
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 | S019 |
Date Received | 02/12/2010 |
Decision Date | 09/15/2010 |
Product Code |
MIR |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AUTOMATING THE LOADING OF THE ACCESS SLEEVE AND TO USE AN ALTERNATE MATERIAL VENDOR. |