PMA P100045S061
- Device
- CardioMEMS HF System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100045
- Supplement
- S061
- Product code
- MOM
- Decision date
- 2022-03-31
- Generic name
- System, hemodynamic, implantable
- Approval order statement
- alternate, drop-in replacement printed circuit board assembly components for use with the CardioMEMS CM3100 Hospital System
Current openFDA PMA Record#
- Device
- CardioMEMS HF System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100045
- Supplement
- S061
- Product code
- MOM
- Generic name
- System, hemodynamic, implantable
- Decision date
- 2022-03-31
- Decision code
- OK30
- Date received
- 2022-03-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- alternate, drop-in replacement printed circuit board assembly components for use with the CardioMEMS CM3100 Hospital System