Indications And Contraindications; Indications For Use - Abbott CentriMag Operation Manual

2 INDICATIONS AND CONTRAINDICATIONS

2.1 Indications for Use

TM
The CentriMag Circulatory Support System and its components may be used only for
their intended purpose. The indications for use for the individual system components vary
within the United States. Refer to the table below for specific Indications For Use by
device product name
Product Name and
Market Application
Number
CentriMag
Circulatory Support
System
PMA P170038
CentriMag Right
Ventricular Assist
System (RVAS)
HDE H070004
TM
CentriMag Circulatory Support System Operation Manual (US)
© 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
.
Indications for Use Chart
Refer to Label Part
No.
PL-0047, CentriMag
Circulatory Support
System Operation
Manual
PL-0085, CentriMag
RVAS (Pump) IFU
Required US
Caution
Statement(s)
Federal (U.S.A.) law
restricts this device
to sale, distribution
and use by or on the
order of a physician.
The CentriMag
Circulatory Support
System is indicated
for use as a right
ventricular assist
device
[Humanitarian
Device]. The
System, when used
as a right ventricular
assist device is also
authorized by
Federal law to
Indications for Use
The CentriMag
Circulatory Support
System is indicated
for temporary
circulatory support
for up to 30 days for
one or both sides of
the heart to treat
post-cardiotomy
patients who fail to
wean from
cardiopulmonary
bypass, providing a
bridge to decision
when it is unclear
whether the patient's
heart will recover or
whether the patient
will need alternative,
longer-term therapy
[PMA Approved
Device].
The CentriMag
Circulatory Support
System is indicated
for use as a right
ventricular assist
device
[Humanitarian
Device]. The
System, when used
as a right ventricular
assist device is also
authorized by
Federal law to
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