|
Device | POSSIS ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM-SPIROFLEX CATHETER |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. One Scimed Place Maple Grove, MN 55311-1566 |
PMA Number | P980037 |
Supplement Number | S017 |
Date Received | 11/29/2005 |
Decision Date | 01/25/2007 |
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 XMI-RX CATHETER RESULTING IN A NEW CATHETER CALLED SPIROFLEX. |