Quill

Main information

  • Trade name:
  • Quill Monoderm Knotless Tissue-Closure Device (PGA-PCL) - Suture, poliglecaprone
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Quill Monoderm Knotless Tissue-Closure Device (PGA-PCL) - Suture, poliglecaprone
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217966
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217966

The Critical Group Pty Ltd - Quill Monoderm Knotless Tissue-Closure Device (PGA-PCL) - Suture,

poliglecaprone

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

2/12/2013

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 Monoderm Knotless Tissue-Closure Device (PGA-PCL) - Suture, poliglecaprone

Product Type

Single Device Product

Effective date

2/12/2013

GMDN

45814 Suture, poliglecaprone

Functional description

The Quill Monoderm knotless tissue closure device is a synthetic absorbable monofilament suture

prepared from a co-polymer of glycolide and e-caprolactone. The device 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 Monoderm sutures are indicated for use in soft tissue approximation where the use of

absorbable sutures is appropriate.

Variant information

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

Length (mm) 12-70

Shape (of tip) Cutting - Straight

Shape (of tip) Reverse Cutter - 3/8 Circle

Shape (of tip) Reverse Cutter - 1/2 Circle

Shape (of tip) Diamond 3/8 Circle

Length (cm) 30 x 30 (Barb Length)

Length (cm) 16 x 16 (Barb Length)

Length (cm) 14 x 14 (Barb Length)

Length (cm) 7 x 7 (Barb Length)

Length (cm) 3.5 x 3.5 (Barb Length)

Shape (of tip) Diamond 1/2 Circle

Suture, gauge 0 - 3.0 USP Diameter

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 12:25:39 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