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: BD PrepStain System
• Generic Name: Processor, cervical cytology slide, automated
• Applicant: Bd Diagnostic Systems; 4025 Stirrup Creek Dr., Suite 400; Durham, NC 27703
• PMA Number: P970018
• Supplement Number: S036
• Date Received: 10/10/2017
• Decision Date: 06/21/2018
• Product Code: MKQ
• Advisory Committee: Pathology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of manufacturing site change.