PMA P030004S036
- Device
- Apollo™ Onyx™ Delivery Micro Catheter
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S036
- Product code
- MFE
- Decision date
- 2024-11-07
- Classification
- Neurology
- Generic name
- Agent, injectable, embolic
- Approval order statement
- a change in sequence of in-process quality control tests for tensile strength and static burst pressure without changing the test methods themselves
Current openFDA PMA Record#
- Device
- Apollo™ Onyx™ Delivery Micro Catheter
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S036
- Product code
- MFE
- Generic name
- Agent, injectable, embolic
- Decision date
- 2024-11-07
- Decision code
- OK30
- Date received
- 2024-10-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change in sequence of in-process quality control tests for tensile strength and static burst pressure without changing the test methods themselves