|
Device | EXPRESS LD MONORAIL ILIAC PREMOUNTED STENT SYSTEM |
Generic Name | STENT, ILIAC |
Applicant | BOSTON SCIENTIFIC CORPORATION One Scimed Place Maple Grove, MN 55311 |
PMA Number | P090003 |
Supplement Number | S014 |
Date Received | 07/13/2012 |
Decision Date | 11/05/2012 |
Product Code |
NIO |
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 | Yes |
Approval Order Statement APPROVAL FOR USE OF AN ALTERNATE CLEANING PROCEDURE. |