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: VASCADE VASCULAR CLOSURE SYSTEM
• Generic Name: Device, hemostasis, vascular
• Applicant: Cardiva Medical, Inc.; 2900 Lakeside Dr., Suite 160; Santa Clara, CA 95054
• PMA Number: P120016
• Supplement Number: S022
• Date Received: 01/17/2017
• Decision Date: 02/15/2017
• Product Code: MGB
• Advisory Committee: Cardiovascular
• 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  
Addition of a new test method, the Distal Outer Sleeve Joint Quality Check.