PMA P100045S051
- Device
- CardioMEMS I3 Patient Electronics System (PES)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100045
- Supplement
- S051
- Product code
- MOM
- Decision date
- 2021-04-22
- Generic name
- System, hemodynamic, implantable
- Approval order statement
- Replacement of fan component used in CardioMEMS I3 Patient Electronic System (PES).
Current openFDA PMA Record#
- Device
- CardioMEMS I3 Patient Electronics System (PES)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100045
- Supplement
- S051
- Product code
- MOM
- Generic name
- System, hemodynamic, implantable
- Decision date
- 2021-04-22
- Decision code
- OK30
- Date received
- 2021-03-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacement of fan component used in CardioMEMS I3 Patient Electronic System (PES).