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 MVP XL VVCS Model 800-1014XL
• Generic Name: Device, hemostasis, vascular
• Applicant: Cardiva Medical, Inc.; 2900 Lakeside Dr., Suite 160; Santa Clara, CA 95054
• PMA Number: P120016
• Supplement Number: S039
• Date Received: 09/30/2025
• Decision Date: 03/27/2026
• Product Code: MGB
• Advisory Committee: Cardiovascular
• Clinical Trials: NCT06615154
• Supplement Type: Panel 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  
The VASCADE MVP XL Venous Vascular Closure System (VVCS) Model 800-1014XL is indicated for the percutaneous closure of femoral venous access sites while reducing time to ambulation, total post-procedure time, time to hemostasis, and time to discharge eligibility in patients who have undergone catheter-based procedures utilizing 8 – 14F inner diameter (17F maximum outer diameter) procedural sheaths, with single or multiple access sites in one or both limbs. The VASCADE MVP XL Venous Vascular Closure System (VVCS) Model 800-1014XL is also indicated for enabling same day discharge in patients who have undergone catheter-based cardiac arrhythmia ablation procedures utilizing 8 – 14F inner diameter (17F maximum outer diameter) procedural sheaths, with single or multiple access sites in one or both limbs.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2