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: THINPREP PROCESSOR,
• Generic Name: Processor, cervical cytology slide, automated
• Applicant: Hologic, Inc.; 250 Campus Dr.; Malborough, MA 01752
• PMA Number: P950039
• Supplement Number: S035
• Date Received: 10/05/2016
• Decision Date: 10/26/2016
• Product Code: MKQ
• Advisory Committee: Pathology
• Supplement Type: Special (Immediate Track)
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of labeling changes for the ThinPrep® 3000 Processor.