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 PRESSURE MEASUREMENT SYSTEM |
Generic Name | System, hemodynamic, implantable |
Applicant | Abbott Medical 387 Technology Circle, NW Suite 500 Atlanta, GA 30313 |
PMA Number | P100045 |
Supplement Number | S008 |
Date Received | 03/15/2016 |
Decision Date | 05/02/2016 |
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 an alternate contract sterilizer site located at St Jude Medical-Sylmar, 15900 Valley View Court, Sylmar, California, 93342, to perform as an alternate ethylene oxide sterilization vendor for the CardioMEMS PA Sensor and Delivery Catheter. |
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