PMA P100045S044
- Device
- CardioMEMS HF System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100045
- Supplement
- S044
- Product code
- MOM
- Decision date
- 2020-07-28
- Generic name
- System, hemodynamic, implantable
- Approval order statement
- Addition of alternate manufacturing equipment and an alternate supplier for the metal deposition phase of the Pressure Sensor assembly.
Current openFDA PMA Record#
- Device
- CardioMEMS HF System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100045
- Supplement
- S044
- Product code
- MOM
- Generic name
- System, hemodynamic, implantable
- Decision date
- 2020-07-28
- Decision code
- OK30
- Date received
- 2020-06-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of alternate manufacturing equipment and an alternate supplier for the metal deposition phase of the Pressure Sensor assembly.