PMA P100045S018
- Device
- CARDIOMEMS HF SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100045
- Supplement
- S018
- Product code
- MOM
- Decision date
- 2017-02-14
- Classification
- System, Hemodynamic, Implantable
- Generic name
- System, hemodynamic, implantable
- Approval order statement
- Approval for changes to the protocol, such as Quality of Life evaluations as well as minor clarifications for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- CARDIOMEMS HF SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100045
- Supplement
- S018
- Product code
- MOM
- Generic name
- System, hemodynamic, implantable
- Decision date
- 2017-02-14
- Decision code
- APPR
- Date received
- 2016-12-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval for changes to the protocol, such as Quality of Life evaluations as well as minor clarifications for the post-approval study (PAS) protocol.