Silhouette

Main information

  • Trade name:
  • Silhouette Soft - Lift thread, absorbable
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Silhouette Soft - Lift thread, absorbable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221747
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221747

Austramedex (Vic) Pty Ltd - Silhouette Soft - Lift thread, absorbable

ARTG entry for

Medical Device Included Class III

Sponsor

Austramedex (Vic) Pty Ltd

Postal Address

PO Box 183,HALLAM, VIC, 3803

Australia

ARTG Start Date

27/03/2014

Product category

Medical Device Class III

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Silhouette Lift Inc

1 Technology Drive

Irvine, CA, 92618

United States Of America

Products

1. Silhouette Soft - Lift thread, absorbable

Product Type

Single Device Product

Effective date

3/06/2015

GMDN

46859 Lift thread, absorbable

Functional description

Silhouette Soft Suture is a clear resorbable (polylactic acid) material and resorbable cones (lactide

glycolide 82-18). Each suture has two series of cones. Each series has the same number of cones

oriented in opposite (bidirectional) direction towards each extremity of the suture. Cones are separated by

tied knots placed at 0.5 or 0.8cm from each other and free knots floating between the knots. Each suture

has 2 needles attached.

Intended purpose

Silhouette Soft is indicated for use in plastic and reconstructive surgery in aesthetic plastic and surgical

procedures for approximation of subcutaneous tissue to elevate and reposition sagging skin to restore or

enhance a patients facial appearance.

Variant information

Length (cm) 26.8 ± 30 suture length

Shape cones 8-16

Model number (see guidance docs) Model number:

SM22, SM23, SM25

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 09.11.2017 at 11:58:27 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information