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: PASCAL Precision – Implant System (PASCAL Implant, 10mm), PASCAL Precision – Implant System (PASCAL Ace Implant, 5mm)
• Generic Name: Mitral valve repair devices
• Applicant: Edwards Lifesciences, LLC; One Edwards Way; Irvine, CA 92614
• PMA Number: P220003
• Supplement Number: S001
• Date Received: 10/12/2022
• Decision Date: 10/19/2022
• Product Code: NKM
• 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  
Change in yarn extruder and an additional bias cloth manufacturing step.