|
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 | S070 |
Date Received | 10/27/2022 |
Decision Date | 11/22/2022 |
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 Addition of an alternative heat seal coating to be used on the packaging. |