PMA P100018S007

Device: PIPELINE EMBOLIZATION DEVICE, PIPELINE EMBOLIZATION DEVICE
Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
PMA number: P100018
Supplement: S007
Product code: OUT
Decision date: 2013-05-09
Classification: Intracranial Aneurysm Flow Diverter
Generic name: Intracranial aneurysm flow diverter
Approval order statement: MANUFACTURING PROCESS CHANGE FOR THE PROTECTIVE COIL OF THE PIPELINEEMBOLIZATION DEVICE DELIVERY SYSTEM.

Current openFDA PMA Record#

Device: PIPELINE EMBOLIZATION DEVICE, PIPELINE EMBOLIZATION DEVICE
Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
PMA number: P100018
Supplement: S007
Product code: OUT
Generic name: Intracranial aneurysm flow diverter
Decision date: 2013-05-09
Decision code: OK30
Date received: 2013-04-11
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: MANUFACTURING PROCESS CHANGE FOR THE PROTECTIVE COIL OF THE PIPELINEEMBOLIZATION DEVICE DELIVERY SYSTEM.