Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | Cardiomems HF System |
Generic Name | System, hemodynamic, implantable |
Applicant | Abbott Medical 387 Technology Circle, NW Suite 500 Atlanta, GA 30313 |
PMA Number | P100045 |
Supplement Number | S050 |
Date Received | 03/09/2021 |
Decision Date | 04/06/2021 |
Product Code |
MOM |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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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