|
Device | WALLSTENT (TIPS/LLIAC/VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM |
Generic Name | Stent, central venous |
Applicant | BOSTON SCIENTIFIC CORPORATION ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P980033 |
Supplement Number | S017 |
Date Received | 04/08/2010 |
Decision Date | 01/07/2011 |
Product Code |
QKJ |
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. |