PMA P100045S079
- Device
- CardioMEMS HF System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100045
- Supplement
- S079
- Product code
- MOM
- Decision date
- 2025-09-24
- Classification
- Cardiovascular
- Generic name
- System, hemodynamic, implantable
- Approval order statement
- Approval for updates to CardioMEMS Backend Web Application.
Current openFDA PMA Record#
- Device
- CardioMEMS HF System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100045
- Supplement
- S079
- Product code
- MOM
- Generic name
- System, hemodynamic, implantable
- Decision date
- 2025-09-24
- Decision code
- APPR
- Date received
- 2024-10-22
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for updates to CardioMEMS Backend Web Application.