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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceCARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM
Generic NameSystem, hemodynamic, implantable
ApplicantABBOTT MEDICAL
387 Nerem St. NW
Suite #500
Atlanta, GA 30313
PMA NumberP100045
Supplement NumberS008
Date Received03/15/2016
Decision Date05/02/2016
Product Code MOM 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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