PMA P030004S024
- Device
- Apollo Onyx Delivery Micro Catheter
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S024
- Product code
- MFE
- Decision date
- 2020-06-29
- Generic name
- Agent, injectable, embolic
- Approval order statement
- Moving the braiding and annealing operations for the Onyx Apollo Delivery Micro Catheter from the clean room to a non-controlled environment.
Current openFDA PMA Record#
- Device
- Apollo Onyx Delivery Micro Catheter
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S024
- Product code
- MFE
- Generic name
- Agent, injectable, embolic
- Decision date
- 2020-06-29
- Decision code
- OK30
- Date received
- 2020-06-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Moving the braiding and annealing operations for the Onyx Apollo Delivery Micro Catheter from the clean room to a non-controlled environment.