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: ZIMMER DIRECT CURRENT BONE GROWTH STIMULATOR
• Generic Name: Stimulator, invasive bone growth
• Applicant: Zimmer, Inc.; P.O. Box 708; Warsaw, IN 46581
• PMA Number: P790008
• Supplement Number: S004
• Date Received: 03/02/1988
• Decision Date: 04/21/1988
• Product Code: LOE
• Advisory Committee: Orthopedic
• Supplement Type: 30-Day Supplement
• Supplement Reason: Other
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No