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: S016
• Date Received: 08/31/2020
• Decision Date: 02/17/2021
• Product Code: DSQ
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - PAS
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for updates to the Instructions for Use based on the post-approval study results.