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Device | ANGIOJET RHEDOLYTIC THROMBECTOMY SYSTEM CORONARY USE |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. One Scimed Place Maple Grove, MN 55311-1566 |
PMA Number | P980037 |
Supplement Number | S011 |
Date Received | 06/16/2004 |
Decision Date | 06/30/2004 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE ADDITION OF A BOXED WARNING REGARDING USE IN PULMONARY VASCULATURE TO ALL POSSIS ANGIOJET CATHETER INSTRUCTION FOR USE DOCUMENTS. |