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: BIO OSTEOGEN SYSTEM 204
• 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: S006
• Date Received: 04/15/1985
• Decision Date: 08/20/1985
• Reclassified Date: 05/18/2026
• Product Code: LOF
• Advisory Committee: Orthopedic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No