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 | St. Jude Medical 387 technology circle nw suite 500 atlanta, GA 30313 |
PMA Number | P100045 |
Supplement Number | S039 |
Date Received | 03/13/2019 |
Decision Date | 03/26/2019 |
Product Code |
MOM |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Change the air sampling method of the Controlled Access Environment located at the Atlanta facility. |
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