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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.
 
DeviceEXCOR IKUS Driver
Generic NameVentricular (assist) bypass
ApplicantBerlin Heart, Inc.
9391 Grogan'S Mill Rd.
Suite A-6
The Woodlands, TX 77380
PMA NumberP160035
Supplement NumberS008
Date Received07/15/2019
Decision Date02/20/2020
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a change to implement and qualify a new supplier for the batteries in the IKUS Driving Unit.
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