PMA P100018S021
- Device
- Pipeline Flex Embolization Device
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- PMA number
- P100018
- Supplement
- S021
- Product code
- OUT
- Decision date
- 2019-07-15
- Classification
- Intracranial Aneurysm Flow Diverter
- Generic name
- Intracranial aneurysm flow diverter
- Approval order statement
- Manufacturing facility relocation at a metal wire critical component supplier.
Current openFDA PMA Record#
- Device
- Pipeline Flex Embolization Device
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- PMA number
- P100018
- Supplement
- S021
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2019-07-15
- Decision code
- OK30
- Date received
- 2019-07-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing facility relocation at a metal wire critical component supplier.