Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: EXCOR Pediatric Ventricular Assist Device
• Generic Name: Ventricular (assist) bypass
• Applicant: Berlin Heart Inc.; 9391 Grogan's Mill Road, Suite A-6; The Woodlands, TX 77380
• PMA Number: P160035
• Date Received: 08/11/2016
• Decision Date: 06/06/2017
• Product Code: DSQ
• Docket Number: 17M-3580
• Notice Date: 06/09/2017
• Advisory Committee: Cardiovascular
• Clinical Trials: NCT00583661
• Expedited Review Granted?: No
• Combination Product: No
• Recalls: CDRH Recalls

Approval Order Statement  
Approval for the EXCOR® Pediatric Ventricular Assist Device (referred to as EXCOR Pediatric) is intended to provide mechanical circulatory support as a bridge to cardiac transplantation for pediatric patients. Pediatric candidates with severe isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant and require circulatory support may be treated using the EXCOR Pediatric.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress
• Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 ; S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 ; S024 S025 S026 S027 S028 S030 S031 S032 S033 S034 S035 S036 ; S037 S038 S039 S041