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MDEC meeting 2008/2, 13 June 2008

Medical Device Evaluation Committee

Meeting report

The 2008/2 (18th) meeting of the Medical Device Evaluation Committee (MDEC) was held on 13 June 2008. The main points of discussion included:

  • an application by Gyrus Australasia Pty Ltd for the provision of a conformity assessment certificate for Seprapack Bioresorbable Nasal Packing and Sinus Stent for use in patients undergoing nasal/sinus surgery as a space occupying stent to separate and prevent adhesions between mucosal surfaces in the nasal cavity, to help control minimal bleeding following surgery or nasal trauma, and to prevent lateralisation of the middle turbinate during the post operative period.
  • an application by Medtronic Australasia Pty Ltd for the provision of a conformity assessment certificate for Endeavor Resolute Zotarolimus-eluting Coronary Stent with Sprint Technology for improving coronary luminal diameter and reducing restenosis in patients with symptomatic ischemic heart disease.
  • the Evaluation Principles for in-Vitro Fertilisation (IVF) Solutions - IVF Guidelines
  • consideration of the activity reports from the MDEC Subcommittees and Expert Advisory Groups.

The 2008/3 MDEC meeting is proposed for 5 September 2008.

Summary of key resolutions

NOTE: This summary has been prepared to provide rapid advice of the Resolutions of the Medical Device Evaluation Committee (MDEC) at its recent meeting. It should not be assumed that recommendations made to the TGA represent the decisions of the TGA.

Device registrations

MDEC resolved that the following medical device applications should be approved, subject to the resolution of all outstanding matters to the satisfaction of the Committee and the TGA. These recommendations for approval may be subject to specific conditions.

Seprapack Bioresorbable Nasal Packing and Sinus Stent
Gyrus Australasia Pty Ltd
Proposed intended use: Seprapack Bioresorbable Nasal Packing and Sinus Stent is indicated for use in patients undergoing nasal/sinus surgery as a space occupying stent to separate and prevent adhesions between mucosal surfaces in the nasal cavity, to help control minimal bleeding following surgery or nasal trauma, and to prevent lateralisation of the middle turbinate during the post operative period.

Endeavor Resolute Zotarolimus-eluting Coronary Stent with Sprint Technology
Medtronic Australasia Pty Ltd
Proposed intended use: Endeavor Resolute is indicated for improving coronary luminal diameter and reducing restenosis in patients with symptomatic ischemic heart disease.

Evaluation Principles for IVF Solutions - (IVF Guidelines)

RES NO. 2008/9

MDEC accepts the draft guidelines, entitled: Information to be Provided to Support an Application for in Vitro Fertilisation (IVF) Solutions in Australia as the final document as approved by the Biomaterials and Bioengineering Committee, for information to be provided to support an application for conformity assessment of in-vitro fertilisation solutions, subject to the removal of the requirement for patient consent forms to be provided.

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