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Trade Name | ONYX LIQUID EMBOLIC SYSTEM, ONYX HD-500 MODEL 105-8101-500 |
Classification Name | polymerizing, neurovascular embolization material |
Generic Name | polymerizing, neurovascular embolization material |
Applicant |
EV3 INC |
9775 toledo way |
irvine, CA 92618 |
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HDE Number | H060003 |
Supplement Number | S002 |
Date Received | 07/16/2013 |
Decision Date | 08/14/2013 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | Yes |