|
Device | Pipeline Flex Embolization Device |
Generic Name | intracranial aneurysm flow diverter |
Applicant |
Micro Therapeutics, Inc. d/b/a ev3 NEUROVASCULAR |
9775 toledo way |
irvine, CA 92618 |
|
PMA Number | P100018 |
Supplement Number | S022 |
Date Received | 08/21/2019 |
Decision Date | 12/10/2019 |
Product Code |
OUT
|
Advisory Committee |
Neurology |
Supplement Type | normal 180 day track no user fee |
Supplement Reason | location change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product |
No
|
Approval Order Statement
Approval for a manufacturing site located at Medtronic Distribution Center, 4340 Swinnea Road, Memphis, Tennessee 38118 for the repackaging of the Apollo Onyx Delivery Micro Catheter and Pipeline Flex Embolization Device. |