|
Device | ANGIOJET XMI AND XMI-RX CATHETERS |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. One Scimed Place Maple Grove, MN 55311-1566 |
PMA Number | P980037 |
Supplement Number | S016 |
Date Received | 10/17/2005 |
Decision Date | 07/11/2006 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR LABELING CHANGES TO THE IFU FOR THE ANGIOJET XMI AND ANGIOJET XMI-RX CATHETERS FOR USE IN THE CORONARY VASCULATURE. |