PMA P100045S068
- Device
- CardioMEMS HF System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100045
- Supplement
- S068
- Product code
- MOM
- Decision date
- 2023-07-26
- Classification
- Cardiovascular
- Generic name
- System, hemodynamic, implantable
- Approval order statement
- Approval of the revised protocol as well as Statistical Analysis Plan for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- CardioMEMS HF System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100045
- Supplement
- S068
- Product code
- MOM
- Generic name
- System, hemodynamic, implantable
- Decision date
- 2023-07-26
- Decision code
- APPR
- Date received
- 2023-06-22
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol as well as Statistical Analysis Plan for the post-approval study (PAS) protocol.