Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | PIPELINE 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 | S008 |
Date Received | 07/22/2013 |
Decision Date | 10/22/2013 |
Product Code |
OUT |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A DESIGN CHANGE FOR THE SHORTER PIPELINE¿ EMBOLIZATIONDEVICES (PED), MODEL NUMBERS FA-77XXX-XX, WITH LENGTHS BETWEEN 10MM AND 20MM. THIS DESIGN CHANGE INVOLVES REPLACING THE DELIVERY CORE WIRE CURRENTLY AVAILABLE ON THESE SHORTER PED LENGTHS (RM-00013-XX) WITH THE DELIVERY CORE WIRE CURRENTLY AVAILABLE ON THE LONGER PEDLENGTHS (RM-00089-XX), MODEL NUMBERS FA-71XXX-XX, BETWEEN 25MM AND 35MM. |
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