|
Device | WALLSTENT RP ENDOPROSTHESIS AND WALLSTENT ENDOPROSTHESIS (VENOUS) |
Generic Name | Stent, central venous |
Applicant | BOSTON SCIENTIFIC CORPORATION ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P980033 |
Supplement Number | S029 |
Date Received | 11/27/2012 |
Decision Date | 06/18/2013 |
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 USE OF AN ALTERNATE PTFE MATERIAL. |