• 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 | 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.
Classification Namefiller, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
Generic Namerecombinant human bone morphogenetic protein
PMA NumberP000054
Supplement NumberS004
Date Received01/26/2005
Decision Date04/20/2005
Product Code
MPW[ Registered Establishments with MPW ]
Advisory Committee Physical Medicine
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for two changes to the processing of the rhbmp-2 component of the device - the use of a new working cell bank and the use of a longer hold-time (<=120 hours at 2-8 degrees c compared to the current 24 hours) for the matrex cellufine sulfate column.