PMA P030004S008
- Device
- ONYX 18LES & ONYX 34 LES
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S008
- Product code
- MFE
- Decision date
- 2013-10-09
- Classification
- Agent, Injectable, Embolic
- Generic name
- Agent, injectable, embolic
- Approval order statement
- ADD AN ALTERNATE SUPPLIER FOR PYROGEN TESTING.
Current openFDA PMA Record#
- Device
- ONYX 18LES & ONYX 34 LES
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S008
- Product code
- MFE
- Generic name
- Agent, injectable, embolic
- Decision date
- 2013-10-09
- Decision code
- OK30
- Date received
- 2013-09-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADD AN ALTERNATE SUPPLIER FOR PYROGEN TESTING.