Premilene

Main information

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

Documents

Localization

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

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219437
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219437

B Braun Australia Pty Ltd - Premilene Suture - Suture, polypropylene monofilament

ARTG entry for

Medical Device Included Class III

Sponsor

B Braun Australia Pty Ltd

Postal Address

PO Box 6221,BAULKHAM HILLS DC, NSW, 2153

Australia

ARTG Start Date

22/01/2014

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

B Braun Surgical SA

Carretera De Terassa 121

RUBI (BARCELONA), , E-08191

Spain

Products

1. Premilene Suture - Suture, polypropylene monofilament

Product Type

Single Device Product

Effective date

22/01/2014

GMDN

13909 Suture, polypropylene monofilament

Functional description

Non absorbable synthetic monofilament suture made of polypropylene for use in general soft tissue

approximation and/or ligation for use in cardiovascular, ophthalmic and neurological procedures.

Intended purpose

Non absorbable suture indicated particularly for use in cardiovascular surgery and neurosurgery, where

the low thrombogenic properties of polypropylene have a positive influence on would healing. Further

indications are in microsurgery and ophthalmology. Used in vascular surgery, cardiac surgery, plastic &

reconstructive surgery, skin closure (intra/sub/skin), neurosurgery, microsurgery and gastrointestinal

surgery.

Variant information

Suture, needle, physical attributes taper point

Suture, needle, physical attributes trocar point

Suture, needle, physical attributes plastic point

Suture, needle, physical attributes precision point

Suture, needle, physical attributes short cutting point

Suture, needle, physical attributes progressive

curved

Suture, needle, physical attributes straight needle

Suture, needle, physical attributes blunt point

Suture, gauge 10/0 to 2 USP

Suture, no. of strands 1-4

Quantity/pack 6-36

Length (cm) 5 to 240 cm

Suture, colour blue

Suture, needle, physical attributes 3/8 circle

Suture, needle, physical attributes 5/8 circle

Suture, needle, physical attributes straight reverse

cutting needle

Suture, needle, physical attributes round bodied

micro short cutting point break-off

Suture, needle, physical attributes round bodied

micro short cutting point

Suture, needle, physical attributes round bodied

micro break-off

Suture, needle, physical attributes round bodied ski

needle

Suture, needle, physical attributes micro-lancet

needle

Suture, needle, physical attributes curved round

bodied micro-needle

Public Summary

Page 1 of

Produced at 22.11.2017 at 11:35:24 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

Suture, needle, physical attributes hook round bodied

needle

Suture, needle, physical attributes round bodied

needle

Suture, needle, physical attributes round bodied

microvascular needle

Suture, needle, physical attributes round bodied

micro-needle

Suture, needle, physical attributes reverse cutting

needle

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 2 of

Produced at 22.11.2017 at 11:35:24 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