INVESTIGATOR'S BROCHURE (IB) 1. General 1.1 Introduction Information Brochure shall contain, as a minimum, information on all topics listed in this Table. 1.2 Identification of the IB (a) Name of the investigational medical device. (b) Document reference number, if any. (c) Version or date of the IB. (d) Confidentiality statement, if appropriate. (e) Summary of the revision history in case of amendments, if appropriate. (f) A version or issue number and reference number, if any, with page number and the total number of pages on each page of the IB.
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