|
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 | S016 |
Date Received | 09/14/2017 |
Decision Date | 10/11/2017 |
Product Code |
OUT |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Change to the hypotube manufacturing process of a sub tier supplier in order to improve overall component yield and reduce scrap. |