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 | S011 |
Date Received | 09/30/2016 |
Decision Date | 10/19/2016 |
Product Code |
MOM |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes to the Hospital System Guide for the CardioMEMS HF System to clarify the instructions for powering down the hospital electronics unit (CM3000). |
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