- Device
- Apollo Onyx Delivery Micro Catheter 1.5cm, Apollo Onyx Delivery Micro Catheter 3.0cm
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S029
- Product code
- MFE
- Generic name
- Agent, injectable, embolic
- Decision date
- 2022-07-28
- Decision code
- OK30
- Date received
- 2022-06-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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.