PMA P100045S062
- Device
- CardioMEMS PA Sensor and Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100045
- Supplement
- S062
- Product code
- MOM
- Decision date
- 2022-04-11
- Generic name
- System, hemodynamic, implantable
- Approval order statement
- Implement an additional sterilization chamber for the CardioMEMS PA Sensor and Delivery System (CM2000) at the Abbott Sylmar, CA facility.
Current openFDA PMA Record#
- Device
- CardioMEMS PA Sensor and Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100045
- Supplement
- S062
- Product code
- MOM
- Generic name
- System, hemodynamic, implantable
- Decision date
- 2022-04-11
- Decision code
- OK30
- Date received
- 2022-03-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement an additional sterilization chamber for the CardioMEMS PA Sensor and Delivery System (CM2000) at the Abbott Sylmar, CA facility.