PMA P100018S001
- Device
- PIPELINE EMBOLIZATION DEVICE
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- PMA number
- P100018
- Supplement
- S001
- Product code
- OUT
- Decision date
- 2011-06-27
- Generic name
- Intracranial aneurysm flow diverter
- Approval order statement
- APPROVAL OF POST- APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- PIPELINE EMBOLIZATION DEVICE
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- PMA number
- P100018
- Supplement
- S001
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2011-06-27
- Decision code
- APPR
- Date received
- 2011-04-28
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF POST- APPROVAL STUDY PROTOCOL.