|
Device | WALLSTENT™ TIPS Endoprosthesis with Unistep Plus™ Delivery System |
Generic Name | SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P930031 |
Supplement Number | S072 |
Date Received | 06/01/2023 |
Decision Date | 06/14/2023 |
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 Upgrading the control system for the furnace system at the Boston Scientific Corporation (BSC) Galway facility. |