|
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 | S028 |
Date Received | 04/08/2010 |
Decision Date | 01/07/2011 |
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 MODIFIED TEST METHOD AND SPECIFICATION EXTRACTABLES TESTING OF PEBAX RESIN MATERIAL. |