PMA P100018S003
- Device
- PIPELINE EMBOLIZATION DEVICE
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- PMA number
- P100018
- Supplement
- S003
- Product code
- OUT
- Decision date
- 2011-08-30
- Generic name
- Intracranial aneurysm flow diverter
- Approval order statement
- APPROVAL FOR ADDING A WARNING ABOUT ALLERGIES TO METALS USED IN THE DEVICE AND CLARIFYING YOUR INSTRUCTIONS FOR UESE.
Current openFDA PMA Record#
- Device
- PIPELINE EMBOLIZATION DEVICE
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- PMA number
- P100018
- Supplement
- S003
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2011-08-30
- Decision code
- APPR
- Date received
- 2011-08-01
- Supplement type
- Special (Immediate Track)
- Approval order statement
- APPROVAL FOR ADDING A WARNING ABOUT ALLERGIES TO METALS USED IN THE DEVICE AND CLARIFYING YOUR INSTRUCTIONS FOR UESE.