Cardiomems HF System
FDA premarket approval P100045/S050 · decided 2021-04-06
Approval details
- PMA number
- P100045
- Supplement
- S050
- 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
- 2021-03-09
- Decision date
- 2021-04-06
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MOM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Atlanta, GA
- Statement
- Approval for manufacturing sites located at Midwest Sterilization Corporation, PO BOX 411, 1204 Lenco Avenue, Jackson, Missouri, USA, FEI: 1928237 for Ethylene Oxide Sterilization and Sterigenics US, LLC, 5725 W. Harold Gatty Drive, Salt Lake City, Utah, USA, FEI: 1721676 for Ethylene Oxide Sterilization.
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