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: Angio-Seal VIP Vascular Closure Devices
• Generic Name: Device, hemostasis, vascular
• Applicant: Terumo Medical Corporation; 950 Elkton Blvd.; Elkton, MD 21921
• PMA Number: P930038
• Supplement Number: S102
• Date Received: 07/26/2024
• Decision Date: 08/23/2024
• 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  
re-establishment of the verification dose and sterilization minimum dose, and addition of a new alternative facility for quarterly bioburden and dose audit sterility testing