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Device | ANGIOJET(R) RHEOLYTIC THROMBECTOMY SYSTEM DRIVE UNIT |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. One Scimed Place Maple Grove, MN 55311-1566 |
PMA Number | P980037 |
Supplement Number | S003 |
Date Received | 12/19/2000 |
Decision Date | 11/20/2001 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR REPLACEMENT OF THE OUTFLOW BUBBLE DETECTOR SHUTDOWN FUNCTION ON THE DRIVE UNIT 3000A WITH A VISUAL ALARM THAT IS ACTIVATED WHEN BUBBLES ARE DETECTED IN THE OUTFLOW LINE. |