PMA P100045S046
- Device
- CardioMEMS HF System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100045
- Supplement
- S046
- Product code
- MOM
- Decision date
- 2020-12-22
- Generic name
- System, hemodynamic, implantable
- Approval order statement
- rework the LCD screens from the CardioMEMS I3 Patient Electronic System (PES) returns inventory and use them in the new PES manufacturing builds
Current openFDA PMA Record#
- Device
- CardioMEMS HF System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100045
- Supplement
- S046
- Product code
- MOM
- Generic name
- System, hemodynamic, implantable
- Decision date
- 2020-12-22
- Decision code
- OK30
- Date received
- 2020-12-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- rework the LCD screens from the CardioMEMS I3 Patient Electronic System (PES) returns inventory and use them in the new PES manufacturing builds