• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
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 NameINFUSE BONE GRAFT
Classification Namebone grafting material, dental, with biologic component
Regulation Number872.3930
Applicant MEDTRONIC INC.
PMA NumberP050053
Supplement NumberS011
Date Received12/23/2008
Decision Date02/20/2009
Product Code
NPZ[ Registered Establishments with NPZ ]
Advisory Committee Dental
Supplement Typereal-time process
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for changes in the exterior cartons used to ship one or more units of infuse bone graft.
-
-