Peri

Main information

  • Trade name:
  • Peri Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement with Adhesive - Staple line-reinforcement strip
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Peri Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement with Adhesive - Staple line-reinforcement strip
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219235
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219235

Baxter Healthcare Pty Ltd - Peri Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement

with Adhesive - Staple line-reinforcement strip

ARTG entry for

Medical Device Included Class III

Sponsor

Baxter Healthcare Pty Ltd

Postal Address

PO Box 88,TOONGABBIE, NSW, 2146

Australia

ARTG Start Date

15/01/2014

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

Synovis Surgical Innovations (A Div of Synovis

Life Technologies Inc)

2575 University Avenue

ST PAUL, MN, 55114

United States Of America

Products

1. Peri Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement with Adhesive - Staple

line-reinforcement strip

Product Type

Single Device Product

Effective date

15/01/2014

GMDN

47818 Staple line-reinforcement strip

Functional description

PSDV allows for neo-collagen formation and neo-vascularization of the implanted device and permits

replacement of the device with host tissue, or remodeling. Peri-Strip Dry with Veritas Collagen Matrix

(PSDV) is prepared from dehydrated bovine pericardium for reinforcement of the staple line during surgical

procedures.

Intended purpose

PSDV Circular (PSDV-C) is intended for use as a prostheses for the surgical repair of soft tissue

deficiencies using surgical staplers when staple line reinforcement is needed. PSDV-C can be used for

reinforcement of staple lines during gastric, bariatric, and small bowel procedures.

Variant information

Size (mm) 21 to 25mm in diameter

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 08:10:25 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

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