Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: N.C.G.T. GRAFT
• Classification Name: tissue graft of 6mm and greater
• Generic Name: vascular graft, bovine
• Applicant: ST. JUDE MEDICAL, INC.
• PMA Number: P800058
• Supplement Number: S003
• Date Received: 03/06/1986
• Decision Date: 07/11/1986
• Product Code: LXA [ Registered Establishments with LXA ]
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No