|
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 | S006 |
Date Received | 12/18/2002 |
Decision Date | 01/14/2003 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATION TO THE MANUFACTURING PROCEDURES FOR MOUNTING OF THE HARDWARE TO THE DRIVE UNIT CONTROL BOARD (I.E., IMPLEMENTATION OF A MINIMUM TORQUE REQUIREMENT). |