Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | ONYX 18, ONYX LIQUID EMBOLIC SYSTEM, ONYX 34,ONYX LIQUID EMBOLIC SYSTEM, APPOLLO ONYX DELIVERY MICRO CATHETER 1.5CM, STR |
Generic Name | Agent, injectable, embolic |
Applicant | EV3 NEUROVASCULAR 9775 Toledo Way Irvine, CA 92618 |
PMA Number | P030004 |
Supplement Number | S009 |
Date Received | 11/18/2015 |
Decision Date | 12/18/2015 |
Product Code |
MFE |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement THE ADDITION OF CLARIFICATION TO THE COATING PROCEDURE REGARDING THE TOP COAT CURING TIME AND THE INCLUSION OF AN ADDITIONAL WEIGHING BALANCE TO THE COATING PREPARATION PROCEDURE FOR THE APOLLO ONYX DELIVERY MICRO CATHETER. |
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