Health Canada
www.hc-sc.gc.ca
Common menu bar links
Institutional links
Drugs and Health Products
Preparation of a Premarket Review Document
for Class III and Class IV Device Licence Applications V.2
Document Change Log
Document Number GD08/Rev00-MDB Replaces GD08/RevDR-MDB DRAFT
File name prmkt2.wpd Replaces prmkt.wpd
Version V2 Replaces V1
Date October 23, 1998 Date April 17, 1998
Change
Location
Nature of Change
1
Title Page, Document Number
Status of document changed from draft (RevDR) to final (Rev00)
2
Entire document
Style of document revised.
3
Page 4, 1.1 Purpose
New paragraph added: "An amended licence application must contain the relevant information to support the safety and effectiveness of the modified device. The information will be required in a format applicable to the modified device class."
4
Page 4, 1.2 Background
Entire section rewritten.
