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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceApollo Onyx Delivery Micro Catheter 1.5cm, Apollo Onyx Delivery Micro Catheter 3.0cm
Generic NameAgent, injectable, embolic
ApplicantEv3 Neurovascular
9775 Toledo Way
Irvine, CA 92618
PMA NumberP030004
Supplement NumberS029
Date Received06/29/2022
Decision Date07/28/2022
Product Code MFE 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Addition of two new sub-tier suppliers of the raw material used in the coating of the Apollo Onyx Delivery Micro Catheter.
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