Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: HYSKON (32% DEXTRAN 70)
• Classification Name: fluid, hysteroscopy
• Generic Name: hysteroscopy fluid
• Applicant: MEDISAN PHARMACEUTICALS, INC.
• PMA Number: N17511
• Supplement Number: S010
• Date Received: 11/09/1993
• Decision Date: 07/18/1995
• Product Code: LTA
• Advisory Committee: Obstetrics/Gynecology
• Supplement Type: normal 180 day track
• Supplement Reason: labeling change - other
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for revised labeling.