PMA P030004S026
- Device
- Apollo Onyx Delivery Micro Catheter
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S026
- Product code
- MFE
- Decision date
- 2021-03-18
- Generic name
- Agent, injectable, embolic
- Approval order statement
- Approval for a new hub design, pouch material change and labeling changes for the Apollo Onyx Delivery Micro Catheter.
Current openFDA PMA Record#
- Device
- Apollo Onyx Delivery Micro Catheter
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S026
- Product code
- MFE
- Generic name
- Agent, injectable, embolic
- Decision date
- 2021-03-18
- Decision code
- APPR
- Date received
- 2020-12-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a new hub design, pouch material change and labeling changes for the Apollo Onyx Delivery Micro Catheter.