PMA P100045S082
- Device
- CardioMEMS™ HF System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100045
- Supplement
- S082
- Product code
- MOM
- Decision date
- 2026-01-09
- Classification
- Cardiovascular
- Generic name
- System, hemodynamic, implantable
- Approval order statement
- implementation of a Delivery System Coating Supplier Process Change for use in the manufacturing of the CardioMEMS PA Sensor and Delivery System
Current openFDA PMA Record#
- Device
- CardioMEMS™ HF System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100045
- Supplement
- S082
- Product code
- MOM
- Generic name
- System, hemodynamic, implantable
- Decision date
- 2026-01-09
- Decision code
- APPR
- Date received
- 2025-05-16
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of a Delivery System Coating Supplier Process Change for use in the manufacturing of the CardioMEMS PA Sensor and Delivery System