|
Device | XMI AND XMI-RX THROMBECTOMY CATHETERS |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. One Scimed Place Maple Grove, MN 55311-1566 |
PMA Number | P980037 |
Supplement Number | S019 |
Date Received | 08/14/2006 |
Decision Date | 02/02/2007 |
Product Code |
MCX |
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 | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A CHANGE IN SEQUENCE FOR THE COATING APPLICATION OF THE CATHETER ASSEMBLY. |