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: S037
• Date Received: 09/11/2023
• Decision Date: 10/11/2023
• Product Code: DSQ
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
change of the production facility of sterile packaging and use of an alternative printing ink