|
Device | WALLSTENT (TIPS/LLIAC/VENOUS) 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 | S029 |
Date Received | 02/10/2011 |
Decision Date | 07/19/2011 |
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 A COMPONENT VENDOR FACILITY SITE CHANGE. |