• 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 NameBIOMET EBI BONE HEALING SYSTEM
Classification Namestimulator, bone growth, non-invasive
Generic Namebone growth stimulator
ApplicantEBI, LLC
PMA NumberP790002
Supplement NumberS032
Date Received04/10/2014
Decision Date05/09/2014
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee Physical Medicine
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of new labeling equipment.
-
-