PMA P100018S013
- Device
- PIPELINE EMBOLIZATION DEVICE
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- PMA number
- P100018
- Supplement
- S013
- Product code
- OUT
- Decision date
- 2014-11-04
- Classification
- Intracranial Aneurysm Flow Diverter
- Generic name
- Intracranial aneurysm flow diverter
- Approval order statement
- APPROVAL FOR THE MODIFICATION OF SAFETY INFORMATION IN THE LABELING.
Current openFDA PMA Record#
- Device
- PIPELINE EMBOLIZATION DEVICE
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- PMA number
- P100018
- Supplement
- S013
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2014-11-04
- Decision code
- APPR
- Date received
- 2014-10-06
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE MODIFICATION OF SAFETY INFORMATION IN THE LABELING.