|
Device | EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM |
Generic Name | STENT, ILIAC |
Applicant | BOSTON SCIENTIFIC CORPORATION One Scimed Place Maple Grove, MN 55311 |
PMA Number | P090003 |
Supplement Number | S003 |
Date Received | 05/17/2010 |
Decision Date | 10/04/2010 |
Product Code |
NIO |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00352222
|
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 AN ALTERNATE STENT FINISHING PROCESS USING AN AUTOMATED SYSTEM IN PLACE OF THE CURRENT MANUAL SYSTEM. |