FDA.reportPublic FDA data

PMA P100045S050

Device
Cardiomems HF System
Applicant
ABBOTT MEDICAL
PMA number
P100045
Supplement
S050
Product code
MOM
Decision date
2021-04-06
Generic name
System, hemodynamic, implantable
Approval order statement
Approval for manufacturing sites located at Midwest Sterilization Corporation, PO BOX 411, 1204 Lenco Avenue, Jackson, Missouri, USA, FEI: 1928237 for Ethylene Oxide Sterilization and Sterigenics US, LLC, 5725 W. Harold Gatty Drive, Salt Lake City, Utah, USA, FEI: 1721676 for Ethylene Oxide Sterilization.

Current openFDA PMA Record#

Device
Cardiomems HF System
Applicant
ABBOTT MEDICAL
PMA number
P100045
Supplement
S050
Product code
MOM
Generic name
System, hemodynamic, implantable
Decision date
2021-04-06
Decision code
APPR
Date received
2021-03-09
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for manufacturing sites located at Midwest Sterilization Corporation, PO BOX 411, 1204 Lenco Avenue, Jackson, Missouri, USA, FEI: 1928237 for Ethylene Oxide Sterilization and Sterigenics US, LLC, 5725 W. Harold Gatty Drive, Salt Lake City, Utah, USA, FEI: 1721676 for Ethylene Oxide Sterilization.