PMA P100018S008

Device: PIPELINE EMBOLIZATION DEVICE
Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
PMA number: P100018
Supplement: S008
Product code: OUT
Decision date: 2013-10-22
Classification: Intracranial Aneurysm Flow Diverter
Generic name: Intracranial aneurysm flow diverter
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.

Current openFDA PMA Record#

Device: PIPELINE EMBOLIZATION DEVICE
Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
PMA number: P100018
Supplement: S008
Product code: OUT
Generic name: Intracranial aneurysm flow diverter
Decision date: 2013-10-22
Decision code: APPR
Date received: 2013-07-22
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
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.