PMA P100018S010
- Device
- PIPELINE EMBOLIZATION DEVICE
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- PMA number
- P100018
- Supplement
- S010
- Product code
- OUT
- Decision date
- 2014-02-27
- Classification
- Intracranial Aneurysm Flow Diverter
- Generic name
- Intracranial aneurysm flow diverter
- Approval order statement
- STERILIZATION PROCESS CHANGE.
Current openFDA PMA Record#
- Device
- PIPELINE EMBOLIZATION DEVICE
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- PMA number
- P100018
- Supplement
- S010
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2014-02-27
- Decision code
- OK30
- Date received
- 2014-01-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- STERILIZATION PROCESS CHANGE.