Visorb

Main information

  • Trade name:
  • Visorb (PGA) - Suture, polyglycolic acid
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Visorb (PGA) - Suture, polyglycolic acid
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220202
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220202

CP Medical Pty Limited - Visorb (PGA) - Suture, polyglycolic acid

ARTG entry for

Medical Device Included Class III

Sponsor

CP Medical Pty Limited

Postal Address

7 St Raphael Terrace,BUNDALL, QLD, 4217

Australia

ARTG Start Date

17/02/2014

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

CP Medical

803 NE 25th Avenue

Portland, OR, 97232

United States Of America

Products

1. Visorb (PGA) - Suture, polyglycolic acid

Product Type

Single Device Product

Effective date

17/02/2014

GMDN

13908 Suture, polyglycolic acid

Functional description

Visorb is a coated braided polyglycolic acid (PGA)synthetic absorbable suture and is absorbed in 60-90

days

Intended purpose

Visorb is intended for use in general soft tissue approximation including ophthalmic surgery, but not for use

in cardiovascular and neurological approximation.

Variant information

Suture, colour Violet

Suture, needle, physical attributes Conventional

cutting

Suture, needle, physical attributes Reverse cutting

Suture, needle, physical attributes Taper point

Suture, needle, physical attributes Soft cut

Suture, gauge 6.0 - 2 USP

Length (cm) 45-90

Suture, colour Undyed

Suture, needle, physical attributes 1/2 circle

Suture, needle, physical attributes 3/8 circle

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 04:55:33 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