PMA P100045S060
- Device
- CardioMEMS HF System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100045
- Supplement
- S060
- Product code
- MOM
- Decision date
- 2022-03-04
- Generic name
- System, hemodynamic, implantable
- Approval order statement
- Retroactive approval for alternate, drop-in replacement printed circuit board assembly (PCBA) components for use with the CardioMEMS CM1100 Patient Electronics System.
Current openFDA PMA Record#
- Device
- CardioMEMS HF System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100045
- Supplement
- S060
- Product code
- MOM
- Generic name
- System, hemodynamic, implantable
- Decision date
- 2022-03-04
- Decision code
- OK30
- Date received
- 2022-02-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Retroactive approval for alternate, drop-in replacement printed circuit board assembly (PCBA) components for use with the CardioMEMS CM1100 Patient Electronics System.