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: MONOPREP PAP TEST
• Generic Name: Processor, cervical cytology slide, automated
• Applicant: Hologic, Inc.; 250 Campus Dr.; Malborough, MA 01752
• PMA Number: P040052
• Supplement Number: S005
• Date Received: 10/22/2007
• Decision Date: 08/11/2008
• Withdrawal Date: 03/21/2017
• Product Code: MKQ
• Advisory Committee: Pathology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Express GMP Supplement
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR MANUFACTURING SITES LOCATED IN LINCOLNSHIRE, ILLINOIS AND WAUKEGAN, ILLINOIS.