Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
DeviceInfuse Bone Graft
Generic NameFiller, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
ApplicantMedtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
PMA NumberP000054
Supplement NumberS055
Date Received09/18/2019
Decision Date12/13/2019
Product Code MPW 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for an additional configuration of the vials used for the sterile water for injection used to reconstitute the lyophilized rhBMP-2 component of Infuse Bone Graft.
-
-