ev3 Axium™ Prime Detachable Coil System

Singapore - English - HSA (Health Sciences Authority)

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Available from:
COVIDIEN PRIVATE LIMITED
Class:
Class D medical device
Manufactured by:
Micro Therapeutics, Inc. d/b/a EV3 Neurovascular
Therapeutic area:
Neurology
Therapeutic indications:
The eV3 AXIUM™ PRIME Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. The AXIUM™ PRIME Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
Product summary:
Device System Info:[System or Procedure Pack], [Sterile Medical Device], Prosthesis, internal, embolization, intravascular; Models: Axium Prime Bare Helix Configuration - APB-4-6-HX-SS, Axium Prime Bare Helix Configuration - APB-4-8-HX-SS, Axium Prime Bare Helix Configuration - APB-4-10-HX-SS, Axium Prime Bare Helix Configuration - APB-4-12-HX-SS, Axium Prime Bare Helix Configuration - APB-5-10-HX-SS, Axium Prime Bare Helix Configuration - APB-5-15-HX-SS, Axium Prime Bare Helix Configuration - APB-5-20-HX-SS, Axium Prime Bare Helix Configuration - APB-6-12-HX-SS, Axium Prime Bare Helix Configuration - APB-6-20-HX-SS, Axium Prime Bare 3D Configuration - APB-4-6-3D-SS, Axium Prime Bare 3D Configuration - APB-4-8-3D-SS, Axium Prime Bare 3D Configuration - APB-4-10-3D-SS, Axium Prime Bare 3D Configuration - APB-4-12-3D-SS, Axium Prime Bare 3D Configuration - APB-5-8-3D-SS, Axium Prime Bare 3D Configuration - APB-5-10-3D-SS, Axium Prime Bare 3D Configuration - APB-5-15-3D-SS, Axium Prime Bare 3D Configuration - APB-6-10-3D-SS, Axium Prime Bare 3D Configuration - APB-6-15-3D-SS, Axium Prime Bare 3D Configuration - APB-6-20-3D-SS, Instant Detacher - ID-1-5, Axium Prime Bare Helix Configuration - APB-1-1-HX-ES*, Axium Prime Bare Helix Configuration - APB-1-2-HX-ES, Axium Prime Bare Helix Configuration - APB-1-3-HX-ES, Axium Prime Bare Helix Configuration - APB-1.5-1-HX-ES, Axium Prime Bare Helix Configuration - APB-1.5-2-HX-ES, Axium Prime Bare Helix Configuration - APB-1.5-3-HX-ES, Axium Prime Bare Helix Configuration - APB-1.5-4-HX-ES, Axium Prime Bare Helix Configuration - APB-2-1-HX-ES, Axium Prime Bare Helix Configuration - APB-2-2-HX-ES, Axium Prime Bare Helix Configuration - APB-2-3-HX-ES, Axium Prime Bare Helix Configuration - APB-2-4-HX-ES, Axium Prime Bare Helix Configuration - APB-2-6-HX-ES, Axium Prime Bare Helix Configuration - APB-2-8-HX-ES, Axium Prime Bare Helix Configuration - APB-2.5-3-HX-ES, Axium Prime Bare Helix Configuration - APB-2.5-4-HX-ES, Axium Prime Bare Helix Configuration - APB-2.5-6-HX-ES, Axium Prime Bare Helix Configuration - APB-2.5-8-HX-ES, Axium Prime Bare Helix Configuration - APB-3-4-HX-ES, Axium Prime Bare Helix Configuration - APB-3-6-HX-ES, Axium Prime Bare Helix Configuration - APB-3-8-HX-ES, Axium Prime Bare Helix Configuration - APB-3-10-HX-ES, Axium Prime Bare 3D Configuration - APB-1-2-3D-ES, Axium Prime Bare 3D Configuration - APB-1-3-3D-ES, Axium Prime Bare 3D Configuration - APB-1-4-3D-ES, Axium Prime Bare 3D Configuration - APB-1.5-2-3D-ES, Axium Prime Bare 3D Configuration - APB-1.5-3-3D-ES, Axium Prime Bare 3D Configuration - APB-1.5-4-3D-ES, Axium Prime Bare 3D Configuration - APB-2-2-3D-ES, Axium Prime Bare 3D Configuration - APB-2-3-3D-ES, Axium Prime Bare 3D Configuration - APB-2-4-3D-ES, Axium Prime Bare 3D Configuration - APB-2.5-4-3D-ES, Axium Prime Bare 3D Configuration - APB-2.5-6-3D-ES, Axium Prime Bare 3D Configuration - APB-3-4-3D-ES, Axium Prime Bare 3D Configuration - APB-3-6-3D-ES, Axium Prime Bare 3D Configuration - APB-3-8-3D-ES, Axium Prime Bare 3D Configuration - APB-3.5-6-3D-ES, Axium Prime Bare 3D Configuration - APB-3.5-8-3D-ES, Axium Prime Bare 3D Configuration - APB-3.5-10-3D-ES, Axium Prime Frame - FC-3-6-3D, Axium Prime Frame - FC-3-8-3D, Axium Prime Frame - FC-3-10-3D, Axium Prime Frame - FC-3.5-6-3D, Axium Prime Frame - FC-3.5-8-3D, Axium Prime Frame - FC-3.5-10-3D, Axium Prime Frame - FC-4-6-3D, Axium Prime Frame - FC-4-8-3D, Axium Prime Frame - FC-4-10-3D, Axium Prime Frame - FC-4-12-3D, Axium Prime Frame - FC-4-15-3D, Axium Prime Frame - FC-5-8-3D, Axium Prime Frame - FC-5-10-3D, Axium Prime Frame - FC-5-15-3D, Axium Prime Frame - FC-5-20-3D, Axium Prime Frame - FC-6-10-3D, Axium Prime Frame - FC-6-15-3D, Axium Prime Frame - FC-6-20-3D, Axium Prime Frame - FC-6-25-3D, Axium Prime Frame - FC-7-12-3D, Axium Prime Frame - FC-7-15-3D, Axium Prime Frame - FC-7-20-3D, Axium Prime Frame - FC-7-30-3D, Axium Prime Frame - FC-8-15-3D, Axium Prime Frame - FC-8-20-3D, Axium Prime Frame - FC-8-30-3D, Axium Prime Frame - FC-9-20-3D, Axium Prime Frame - FC-9-30-3D, Axium Prime Frame - FC-10-20-3D, Axium Prime Frame - FC-10-30-3D, Axium Prime Frame - FC-10-40-3D, Axium Prime Frame - FC-12-30-3D, Axium Prime Frame - FC-12-40-3D, Axium Prime Frame - FC-12-50-3D, Axium Prime Frame - FC-14-30-3D, Axium Prime Frame - FC-14-40-3D, Axium Prime Frame - FC-14-50-3D, Axium Prime Frame - FC-16-40-3D, Axium Prime Frame - FC-16-50-3D, Axium Prime Frame - FC-18-40-3D, Axium Prime Frame - FC-18-50-3D, Axium Prime Frame - FC-20-50-3D, Axium Prime Frame - FC-22-50-3D, Axium Prime Frame - FC-25-50-3D
Authorization number:
DE0015710
Authorization date:
2014-06-16

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