CardioMEMS HF System
FDA premarket approval P100045/S044 · decided 2020-07-28
Approval details
- PMA number
- P100045
- Supplement
- S044
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CardioMEMS HF System
- Generic name
- System, hemodynamic, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2020-06-29
- Decision date
- 2020-07-28
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MOM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Atlanta, GA
- Statement
- Addition of alternate manufacturing equipment and an alternate supplier for the metal deposition phase of the Pressure Sensor assembly.
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