Sponsor content
381 result(s) found, displaying 261 to 270
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for Endotherapeutics Pty Ltd - SX-ELLA Stent Esophageal Degradable BD Stent (BD Stent) - Oesophageal biodegradable scaffold.
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Cancellation or suspensionRegulatory action due to The Device has been cancelled as the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked. The sponsor did not provide evidence that the device complies with Essential Principles 1 and 6 prior to the expiry of the suspension period.The grounds for cancellation apply only to SerenoCem Granules BCG050 (the Device) and the cancellation is limited under s41GO to vary ARTG 152441 accordingly., effective 28/02/2018
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for Endotherapeutics Pty Ltd - Endotherapy snare, electrosurgical, single use.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for Endotherapeutics Pty Ltd- Speculum, vaginal, single use.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for Endotherapeutics Pty Ltd - Valve, stopcock, general-purpose.
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Cancellation or suspensionRegulatory action due to Under subsection 41GA(1)(b); there is likely that there are grounds for cancelling this device from the ARTG under subsection GN(1)(b)., effective 31/08/2017
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for Endotherapeutics Pty Ltd - Drain, wound.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for Endotherapeutics Pty Ltd - Knife, haemostatic.
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Cancellation or suspensionRegulatory action due to Cancelled by Secretary - As the sponsor did not provide information to substantiate compliance with the Essential Principles, the sponsor failed to comply with a condition to which inclusion of the kind of device in the ARTG was subject under s41FN(3)(a)., effective 11/08/2017
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Cancellation or suspensionRegulatory action due to Cancelled by Secretary - As the sponsor did not provide information to substantiate compliance with the Essential Principles, the sponsor failed to comply with a condition to which inclusion of the kind of device in the ARTG was subject under s41FN(3)(a)., effective 11/08/2017