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: THE BIOMET EBI BONE HEALING SYSTEM
• Generic Name: Stimulator, bone growth, non-invasive
• Regulation Number: 890.5870
• Applicant: Ahp Eos Buyer, Inc.; 1 Gatehall Dr.; Suite 303; Parsippany, NJ 07054
• PMA Number: P790002
• Supplement Number: S030
• Date Received: 08/13/2013
• Decision Date: 09/12/2013
• Reclassified Date: 05/18/2026
• Product Code: LOF
• Advisory Committee: Orthopedic
• Supplement Type: Special (Immediate Track)
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR IMPLEMENTING A COMPLIMENTARY QUALITY CONTROL PROCEDURE.