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
• Generic Name: Device, hemostasis, vascular
• Applicant: Terumo Medical Corporation; 950 Elkton Blvd.; Elkton, MD 21921
• PMA Number: P930038
• Supplement Number: S078
• Date Received: 09/04/2015
• Decision Date: 09/30/2015
• Product Code: MGB
• Advisory Committee: Cardiovascular
• Supplement Type: Special (Immediate Track)
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR IMPLEMENTATION OF A SUTURE KNOT TEST INSPECTION.