Abbott CentriMag - Indications and Contraindications; Indications for Use

CentriMag
TM
Circulatory Support System Operation Manual (US) Page 6 of 126
© 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
2 INDICATIONS AND CONTRAINDICATIONS
2.1 Indications for Use
The CentriMag
TM
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
.
Indications for Use Chart
Product Name and
Market Application
Number
Refer to Label Part
No.
Required US
Caution
Statement(s)
Indications for Use
CentriMag
Circulatory Support
System
PMA P170038
PL-0047, CentriMag
Circulatory Support
System Operation
Manual
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 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].
CentriMag Right
Ventricular Assist
System (RVAS)
HDE H070004
PL-0085, CentriMag
RVAS (Pump) IFU
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
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