Quill

Main information

  • Trade name:
  • Quill PDO Knotless Tissue Closure Device (Polydioxone) - Suture, polydioxanone
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Quill PDO Knotless Tissue Closure Device (Polydioxone) - Suture, polydioxanone
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217806
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217806

The Critical Group Pty Ltd - Quill PDO Knotless Tissue Closure Device (Polydioxone) - Suture,

polydioxanone

ARTG entry for

Medical Device Included Class III

Sponsor

The Critical Group Pty Ltd

Postal Address

PO Box 6466,BAULKHAM HILLS BUSINESS CENTRE, NSW, 2153

Australia

ARTG Start Date

28/11/2013

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

Angiotech Puerto Rico Inc

Road 459 KM 0.6 Montana Industrial Park

Aguadilla, , 00603

Puerto Rico

Products

1. Quill PDO Knotless Tissue Closure Device (Polydioxone) - Suture, polydioxanone

Product Type

Single Device Product

Effective date

28/11/2013

GMDN

16584 Suture, polydioxanone

Functional description

The Quill PDO knotless tissue closure device of dyed PDO absorbable surgical suture material consists of

barbed suture material, armed with a surgical needle on each end. The barbs allow for tissue

approximation without the need to tie surgical knots.

Intended purpose

The Quill PDO are absorbable synthetic surgical suture intended for use in general soft tissue

approximation but not cardiovascular and neurological procedures, microsurgery or ophthalmic

procedures.

Variant information

Suture, gauge 0 - 4.0 USP Diameter

Length (cm) 7 x 7 (Barb Length)

Length (cm) 3.5 x 3.5 (Barb Length)

Length (cm) 10 x 10 (Barb Length)

Length (cm) 14 x 14 (Barb Length)

Length (cm) 24 x 24 (Barb Length)

Length (cm) 30 x 30 (Barb Length)

Length (cm) 36 x 36 (Barb Length)

Length (cm) 40 x 40 (Barb Length)

Length (cm) 45 x 45 (Barb Length)

Shape (of tip) Taper 1/2 Circle

Shape (of tip) Diamond 1/2 Circle

Shape (of tip) Diamond 3/8 Circle

Length (cm) Reverse Cutting - 1/2 Circle

Shape (of tip) Taper Cutting - Straight

Shape (of tip) Taper - Straight

Length (mm) 12 - 50

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 10.11.2017 at 12:55:54 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