- Device
- Apollo Onyx Delivery Micro Catheter
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S017
- Product code
- MFE
- Generic name
- Agent, injectable, embolic
- Decision date
- 2020-06-15
- Decision code
- APPR
- Date received
- 2019-03-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for a labeling change for the Apollo Onyx Delivery Micro Catheter to include the results of the Apollo Onyx Delivery Micro Catheter Post Market Safety Study (APOLLO PMS).