Prolene

Main information

  • Trade name:
  • Prolene EVERPOINT Suture - Suture, polypropylene monofilament
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Prolene EVERPOINT Suture - Suture, polypropylene monofilament
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217590
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217590

Johnson & Johnson Medical Pty Ltd - Prolene EVERPOINT Suture - Suture, polypropylene monofilament

ARTG entry for

Medical Device Included Class III

Sponsor

Johnson & Johnson Medical Pty Ltd

Postal Address

PO Box 134,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

21/11/2013

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

Ethicon LLC

Highway 183 Km 8.3

Po Box 982

SAN LORENZO PUERTO RICO, ,

Puerto Rico

Products

1. Prolene EVERPOINT Suture - Suture, polypropylene monofilament

Product Type

Single Device Product

Effective date

20/06/2017

GMDN

13909 Suture, polypropylene monofilament

Functional description

Prolene polypropylene Suture is a monofilament, synthetic, non-absorbable, sterile surgical suture which is

available in undyed or dyed blue to enhance visibility.

Intended purpose

Indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular,

ophthalmic and neurological procedures.

Variant information

Suture, needle, physical attributes Curved needle

Suture, needle, physical attributes Straight needle

Suture, needle, physical attributes Needle Length

(mm) 6.5 - 13

Suture, needle, physical attributes Needle Diameter

(mm) 0.1524 - 0.2667

Length (cm) Suture Length 7 - 150cm

Suture, gauge 0.2 - 5.0 (Metric)

Suture, colour Dyed (Blue)

Suture, colour Undyed

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 01:45:45 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