Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: PASCAL Precision Transcatheter Valve Repair System
• Generic Name: Mitral valve repair devices
• Applicant: Edwards Lifesciences, LLC; One Edwards Way; Irvine, CA 92614
• PMA Number: P220003
• Date Received: 03/14/2022
• Decision Date: 09/14/2022
• Product Code: NKM
• Docket Number: 22M-2268
• Notice Date: 09/16/2022
• Advisory Committee: Cardiovascular
• Clinical Trials: NCT03706833
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No
• Recalls: CDRH Recalls

Approval Order Statement  
Approval for the PASCAL Precision Transcatheter Valve Repair System. This device is indicated for the percutaneous reduction of significant, symptomatic mitral regurgitation (MR >= 3+) due to primary abnormality of the mitral apparatus (degenerative MR) in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the MR.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress
• Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 ; S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 ; S024 S025 S026