PMA P100045S086
- Device
- Next Gen Patient System – CM1200 CardioMEMS HERO Device
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100045
- Supplement
- S086
- Product code
- MOM
- Decision date
- 2026-02-27
- Classification
- Cardiovascular
- Generic name
- System, hemodynamic, implantable
- Approval order statement
- Approval for the CardioMEMS HERO Device, a new version of the patient electronics system.
Current openFDA PMA Record#
- Device
- Next Gen Patient System – CM1200 CardioMEMS HERO Device
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100045
- Supplement
- S086
- Product code
- MOM
- Generic name
- System, hemodynamic, implantable
- Decision date
- 2026-02-27
- Decision code
- APPR
- Date received
- 2025-08-29
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the CardioMEMS HERO Device, a new version of the patient electronics system.