PMA P030004S028
- Device
- Apollo™ Onyx™ Delivery Micro Catheter 1.5 cm, Apollo™ Onyx™ Delivery Micro Catheter 3.0 cm
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S028
- Product code
- MFE
- Decision date
- 2021-09-14
- Generic name
- Agent, injectable, embolic
- Approval order statement
- Change to add an alternate test equipment for pouch seal tensile testing.
Current openFDA PMA Record#
- Device
- Apollo™ Onyx™ Delivery Micro Catheter 1.5 cm, Apollo™ Onyx™ Delivery Micro Catheter 3.0 cm
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S028
- Product code
- MFE
- Generic name
- Agent, injectable, embolic
- Decision date
- 2021-09-14
- Decision code
- OK30
- Date received
- 2021-09-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to add an alternate test equipment for pouch seal tensile testing.