Device Dossier

Guidant Stylets - Stylet, catheter

Device Dossier for Guidant Stylets - Stylet, catheter (Stylet, catheter, Class IIb, sponsor Boston Scientific). ARTG record, intended purpose, GMDN…

Intended purpose

A wire that is run through a lead to render it stiff in order to facilitate its introduction into the body

Functional description

Wires of various lengths that are run through leads to render them stiff in order to facilitate their introduction into the body. Note: Stylets have been evaluated as part of included submissions for Leads by Guidant Australia. E.g. ARTG 106472 Reliance SG Active; ARTG 106473 Reliance G Active; ARTG 119238; Reliance S; Please refer to Mike Flood for submission approach communicated to Guidant (Fiona Smith),indicating that no further information will be required for the subject application

TGA Public Summary