Premarket Approval (PMA)

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.

• Device: EXCOR Pediatric Ventricular Assist Device
• Generic Name: Ventricular (assist) bypass
• Applicant: Berlin Heart, Inc.; 9391 Grogan'S Mill Rd.; Suite A-6; The Woodlands, TX 77380
• PMA Number: P160035
• Supplement Number: S001
• Date Received: 06/29/2017
• Decision Date: 05/21/2018
• Product Code: DSQ
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - OSB
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of the protocol for the post-approval study protocol.