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: MONOPREP PAP TEST
• Classification Name: processor, cervical cytology slide, automated
• Generic Name: kit,cervical smear
• Applicant: MONOGEN, INC.
• PMA Number: P040052
• Supplement Number: S001
• Date Received: 05/03/2006
• Decision Date: 12/14/2007
• Product Code: MKQ [ Registered Establishments with MKQ ]
• Advisory Committee: Pathology
• Supplement Type: normal 180 day track no user fee
• Supplement Reason: postapproval protocol or modification to a protocol
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval of the post-approval study.