PMA P030004S013
- Device
- Apollo Onyx Delivery Micro Catheter, 1.5cm, Straight/Apollo Onyx Delivery Micro Catheter, 3.0cm, Straight
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S013
- Product code
- MFE
- Decision date
- 2017-10-17
- Classification
- Agent, Injectable, Embolic
- Generic name
- Agent, injectable, embolic
- Approval order statement
- Modifications and replacement of the hub mold.
Current openFDA PMA Record#
- Device
- Apollo Onyx Delivery Micro Catheter, 1.5cm, Straight/Apollo Onyx Delivery Micro Catheter, 3.0cm, Straight
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S013
- Product code
- MFE
- Generic name
- Agent, injectable, embolic
- Decision date
- 2017-10-17
- Decision code
- OK30
- Date received
- 2017-09-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications and replacement of the hub mold.