Cordella Pulmonary Artery Sensor System
FDA premarket approval P230040/S008 · decided 2024-12-09
Approval details
- PMA number
- P230040
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Cordella Pulmonary Artery Sensor System
- Generic name
- System, hemodynamic, implantable
- Applicant
- Endotronix, Inc.
- Date received
- 2024-11-12
- Decision date
- 2024-12-09
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MOM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Naperville, IL
- Statement
- modifications to the sterility site, processes and packaging
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