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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.
 
DeviceSYNCARDIA COMPANION 2 DRIVER SYSTEM
Classification Nameartificial heart
Generic Nameartificial heart
Applicant
SYNCARDIA SYSTEMS, LLC
1992 e. silverlake rd.
tucson, AZ 85713
PMA NumberP030011
Supplement NumberS016
Date Received06/21/2012
Decision Date08/20/2012
Product Code
LOZ[ Registered Establishments with LOZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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