- Device
- Apollo™ Onyx™ Delivery Micro Catheter
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S041
- Product code
- MFE
- Generic name
- Agent, injectable, embolic
- Decision date
- 2026-04-09
- Decision code
- OK30
- Date received
- 2026-03-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval to replace manually operated components of the 2-Spindle Coil Winder with automated safety features and procedures using the new MCS 3-Spindle coil winder for the Apollo Onyx Delivery Micro Catheter