PMA P100045S047

Device
CardioMEMS HF System
Applicant
ABBOTT MEDICAL
PMA number
P100045
Supplement
S047
Product code
MOM
Decision date
2021-03-12
Generic name
System, hemodynamic, implantable
Approval order statement
Approval for a replacement liquid crystal display (LCD) in the Patient Electronics System.

Current openFDA PMA Record#

Device
CardioMEMS HF System
Applicant
ABBOTT MEDICAL
PMA number
P100045
Supplement
S047
Product code
MOM
Generic name
System, hemodynamic, implantable
Decision date
2021-03-12
Decision code
APPR
Date received
2020-12-15
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a replacement liquid crystal display (LCD) in the Patient Electronics System.