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 | S025 |
Date Received | 10/12/2017 |
Decision Date | 01/05/2018 |
Product Code |
MOM |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval for the addition of a cover for the back of the i3 Patient Electronics System. |
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