CardioMEMS HF System
FDA premarket approval P100045/S075 · decided 2024-05-13
Approval details
- PMA number
- P100045
- Supplement
- S075
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CardioMEMS HF System
- Generic name
- System, hemodynamic, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2024-04-12
- Decision date
- 2024-05-13
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- MOM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Atlanta, GA
- Statement
- an addition of an alternate Ethylene Oxide (EO) gas sterilization vendor, Centerpiece S. de R.L. de C.V., for the CardioMEMS PA Sensor and Delivery System, CM2000
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