|
Device | WALLSTENT(R) TIPS ENDOPROSTHESIS |
Generic Name | SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P930031 |
Supplement Number | S001 |
Date Received | 10/04/1995 |
Decision Date | 01/29/1996 |
Product Code |
MIR |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF 10 MM DIAMETER BY 94 MM LENGTH WALLSTENT TIPS (TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT) ENDOPROSTHESIS |