Stratafix

Main information

  • Trade name:
  • Stratafix Spiral PGA-PCL Knotless Tissue Control Device - Suture, poliglecaprone
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Stratafix Spiral PGA-PCL Knotless Tissue Control Device - Suture, poliglecaprone
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221464
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221464

Johnson & Johnson Medical Pty Ltd - Stratafix Spiral PGA-PCL Knotless Tissue Control Device - Suture,

poliglecaprone

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

19/03/2014

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

Angiotech Puerto Rico Inc

Road 459 KM 0.6 Montana Industrial Park

Aguadilla, , 00603

Puerto Rico

Products

1. Stratafix Spiral PGA-PCL Knotless Tissue Control Device - Suture, poliglecaprone

Product Type

Single Device Product

Effective date

19/03/2014

GMDN

45814 Suture, poliglecaprone

Functional description

Stratafix Spiral PGA-PCL Knotless Tissue Contol Device is an absorbable, unidirectional barbed

monofilament suture armed with a surgical needle at one end, and a Variable Loop Design at the opposite

end to preclude the use of a knot to secure tissue.

Intended purpose

Stratafix Spiral PGA-PCL Knotless Tissue Control Device is indicated for use in soft tissue approximation

where the use of absorbable sutures is appropriate.

Variant information

Suture, needle, physical attributes Length (mm): 17

to 36

Length (cm) 20 to 60

Suture, needle, physical attributes Taper Point

Suture, needle, physical attributes Precision Point

Reverse Cutting

Suture, needle, physical attributes 1/2 circle

Suture, needle, physical attributes 3/8 circle

Suture, gauge 2 to 4 (metric)

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 12:58:28 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