CLINICAL INVESTIGATION REPORT 1. General This table specifies the contents of the cli ...

CLINICAL INVESTIGATION REPORT 1. General This table specifies the contents of the cli ...

CLINICAL INVESTIGATION PLAN 1.1 General 1.1.1 Introduction This document specifies th ...

Investigational medical device and methods 6.1 Investigational medical device descrip ...

(f) animal studies that provide direct evidence of safety and performance of the devi ...

(f) animal studies that provide direct evidence of safety and performance of the devi ...

16.0 Claimed Shelf life: This section should provide information on stability testing ...

18.0 Shipping stability: This section should provide information on shipping stabilit ...