CardioMEMS HF System
FDA premarket approval P100045/S036 · decided 2019-04-04
Approval details
- PMA number
- P100045
- Supplement
- S036
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CardioMEMS HF System
- Generic name
- System, hemodynamic, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2019-01-08
- Decision date
- 2019-04-04
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- MOM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Atlanta, GA
- Statement
- Approval for updates to the software contained in the CardioMEMS I2 Hospital Electronic System and I3 Patient Electronics System.
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