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: HYSKON (32% DEXTRAN 70)
• Generic Name: FLUID, HYSTEROSCOPY
• Applicant: Coopervision Surgical; 95 Corporate Dr.; Trumbull, CT 06611
• PMA Number: N17511
• Supplement Number: S003
• Date Received: 09/10/1982
• Decision Date: 04/22/1983
• Withdrawal Date: 04/14/2009
• Product Code: LTA
• Advisory Committee: Obstetrics/Gynecology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No