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: Infuse™ Bone Graft
• Generic Name: Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
• Applicant: Medtronic Sofamor Danek USA, Inc.; 1800 Pyramid Pl.; Memphis, TN 38132
• PMA Number: P000054
• Supplement Number: S068
• Date Received: 07/21/2022
• Decision Date: 08/09/2022
• Product Code: MPW
• Advisory Committee: Orthopedic
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Replacement of the water purification system used in manufacture of the collagen sponge component.