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: COOK CHORIONIC VILLUS SAMPLING SET
• Generic Name: Catheter, sampling, chorionic villus
• Applicant: Cook Incorporated; 750 Daniels Way; P.O. Box 489; Bloomington, IN 47402
• PMA Number: P900007
• Supplement Number: S004
• Date Received: 04/01/2008
• Decision Date: 05/08/2008
• Product Code: LLX
• Advisory Committee: Obstetrics/Gynecology
• 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  
CHANGE IN THE STERILIZATION AGENT USED IN PROCESSING THE COOK CHORIONIC VILLUS SAMPLING SET.