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: ProCol Vascular Bioprosthesis
• Generic Name: Tissue graft of 6mm and greater
• Applicant: LeMaitre Vascular, Inc.; 63 Second Ave.; Burlington, MA 01803
• PMA Number: P020049
• Supplement Number: S007
• Date Received: 08/20/2018
• Decision Date: 09/19/2018
• Withdrawal Date: 12/15/2023
• Product Code: LXA
• 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  
Implement a change to bioburden test methods.