PMA P030004S043
- Device
- Apollo™ Onyx™ Delivery Micro Catheter
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S043
- Product code
- MFE
- Decision date
- 2026-05-26
- Classification
- Neurology
- Generic name
- Agent, injectable, embolic
- Approval order statement
- approval of a new supplier for the dispenser coil component and its tubing supplier for the Apollo Onyx Delivery Micro Catheter
Current openFDA PMA Record#
- Device
- Apollo™ Onyx™ Delivery Micro Catheter
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S043
- Product code
- MFE
- Generic name
- Agent, injectable, embolic
- Decision date
- 2026-05-26
- Decision code
- OK30
- Date received
- 2026-04-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval of a new supplier for the dispenser coil component and its tubing supplier for the Apollo Onyx Delivery Micro Catheter