Stratafix™

Main information

  • Trade name:
  • Stratafix™ Spiral PDO (Polydioxanone) Knotless Tissue Control Device - Suture, polydioxanone
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Stratafix™ Spiral PDO (Polydioxanone) Knotless Tissue Control Device - Suture, polydioxanone
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216670
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216670

Johnson & Johnson Medical Pty Ltd - Stratafix™ Spiral PDO (Polydioxanone) Knotless Tissue Control

Device - Suture, polydioxanone

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

29/10/2013

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. Stratafix™ Spiral PDO (Polydioxanone) Knotless Tissue Control Device - Suture, polydioxanone

Product Type

Single Device Product

Effective date

29/10/2013

GMDN

16584 Suture, polydioxanone

Functional description

Stratafix™ Spiral PDO Knotless Tissue Control Device is an absorbable, bidirectional-barbed

monofilament suture armed with a surgical needle on each end for tissue closure. The barbs are arrayed in

opposing directions on either side of a transitional, nonbarbed segment. The device is advanced into the

tissue, via surgical needles attached on each end, until the opposing barbs are engaged. The barbs

penetrate into the surrounding tissue and secure the device in place.

Intended purpose

Stratafix™ Spiral PDO is indicated for use in soft tissue approximation where use of absorbable sutures is

appropriate.

Variant information

Length (cm) 24x24

Length (cm) 30x30

Length (cm) 36x36

Suture, gauge 1.5 to 5 (metric)

Suture, needle, physical attributes Length (mm): 18

to 48

Suture, needle, physical attributes 3/8 circle

Suture, needle, physical attributes Diamond Point

Suture, needle, physical attributes Taper Point

Suture, needle, physical attributes Reverse Cutting

Length (cm) 10x10

Length (cm) 7x7

Length (cm) 14x14

Suture, needle, physical attributes 1/2 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 04:33:41 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