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: IMPLANTABLE BONE GROWTH STIMULATOR
• Generic Name: Stimulator, invasive bone growth
• Applicant: Ahp Eos Buyer, Inc.; 1 Gatehall Dr.; Suite 303; Parsippany, NJ 07054
• PMA Number: P790005
• Supplement Number: S006
• Date Received: 04/06/1981
• Decision Date: 07/09/1981
• Product Code: LOE
• Advisory Committee: Orthopedic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No