CardioMEMS PA Sensor and Delivery System
FDA premarket approval P100045/S062 · decided 2022-04-11
Approval details
- PMA number
- P100045
- Supplement
- S062
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CardioMEMS PA Sensor and Delivery System
- Generic name
- System, hemodynamic, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2022-03-14
- Decision date
- 2022-04-11
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MOM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Atlanta, GA
- Statement
- Implement an additional sterilization chamber for the CardioMEMS PA Sensor and Delivery System (CM2000) at the Abbott Sylmar, CA facility.
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