- Device
- Apollo™ Onyx™ Delivery Micro Catheter
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S037
- Product code
- MFE
- Generic name
- Agent, injectable, embolic
- Decision date
- 2024-12-19
- Decision code
- OK30
- Date received
- 2024-12-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for changes in viscosity and solids release testing and specification criteria for components of the hydrophilic coating of the Apollo Onyx Delivery Micro Catheter