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: BIOSTATOR GCIIS
• Generic Name: Controller, closed-loop blood glucose
• Applicant: Bayer Healthcare; 430 S. Beiger St.; Mishawaka, IN 46544
• PMA Number: P790028
• Supplement Number: S001
• Date Received: 10/04/1982
• Decision Date: 11/18/1982
• Withdrawal Date: 10/05/2007
• Product Code: LHE
• Advisory Committee: General Hospital
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No