|
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 | S005 |
Date Received | 07/06/2010 |
Decision Date | 02/03/2011 |
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 MULTIPLE COMPONENT-SPECIFIC MANUFACTURING PROCESS CHANGES. THE DEVICE IS INDICATED FOR THE TREATMENT OF ATHEROSCLEROTIC LESIONS FOUND IN ILIAC ARTERIES UP TO 100 MM IN LENGTH, WITH A REFERENCE DIAMETER OF 6 MM TO 10 MM. |