EN
1.0
PRODUCT DESCRIPTION ............................................................................................................ 2
2.0
INDICATIONS FOR USE ............................................................................................................... 5
3.0
CONTRAINDICATIONS ................................................................................................................ 5
4.0
WARNINGS AND PRECAUTIONS ................................................................................................ 6
5.0
ADVERSE EVENTS ....................................................................................................................... 8
6.0
HOW SUPPLIED .......................................................................................................................... 9
7.0
CLINICAL DATA ......................................................................................................................... 10
8.0
CLINICAL USE INFORMATION .................................................................................................. 11
9.0
DIRECTIONS FOR USE ............................................................................................................... 12
10.0
11.0
DEFINITIONS ............................................................................................................................ 19
12.0
13.0
14.0
DISCLAIMER OF WARRANTY .................................................................................................... 23
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Table of Contents