|
Device | ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. One Scimed Place Maple Grove, MN 55311-1566 |
PMA Number | P980037 |
Supplement Number | S031 |
Date Received | 05/27/2009 |
Decision Date | 07/09/2009 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE ANGIOJET ULTRA THROMBECTOMY SET PACKAGING, AND FOR CHANGES TO THE WASTE BAG AND SPIKE LINE TUBING COMPONENTS OF THE ANGIOJET ULTRA THROMBECTOMY SET. |