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: Aptima HPV Assay
• Generic Name: Kit, rna detection, human papillomavirus
• Applicant: Gen-Probe Incorporated; 10210 Genetic Center Dr.; San Diego, CA 92121
• PMA Number: P100042
• Supplement Number: S021
• Date Received: 02/21/2019
• Decision Date: 03/21/2019
• Product Code: OYB
• Advisory Committee: Microbiology
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Transfer Quality Control testing services for components and raw materials to a separate contractor facility.