TablE Of COnTEnTS
warnInG ......................................................................................................................................3
DEVICE DESCrIPTIOn..................................................................................................................3
COnTraInDICaTIOnS .................................................................................................................3
POTEnTIal COMPlICaTIOnS ....................................................................................................4
warnInGS anD PrECaUTIOnS ..............................................................................................4
InSTrUCTIOnS fOr USE ............................................................................................................5
HOw SUPPlIED.............................................................................................................................6
ClInICal STUDIES .......................................................................................................................6
aDVErSE EVEnTS ........................................................................................................................9
lOnG-TErM fOllOw-UP ..........................................................................................................10
rEfErEnCES................................................................................................................................11
warranTy .................................................................................................................................12
2
C
E
C
ph
w
C
da
Fo
re
de
re
an
tr
de
A
an
D
Th
de
bl
ca
Th
vi
Ea
m
Th
as
C
•