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.
 
DeviceEXOGEN 4000+ BONE HEALING SYSTEM
Generic NameStimulator, ultrasound and muscle, for use other than applying therapeutic deep
ApplicantBIOVENTUS LLC
4721 EMPEROR BLVD SUITE 100
DURHAM, NC 27703
PMA NumberP900009
Supplement NumberS022
Date Received12/16/2005
Decision Date06/26/2006
Product Code LPQ 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE MODIFICATION OF THE EXISTING EXOGEN 2000+ AND EXOGEN 3000 LOW INTENSITY ULTRASOUND FRACTURE TREATMENT SYSTEMS - SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) TO THE EXOGEN 4000+. THE EXOGEN 4000+ IS MODIFIED TO INCORPORATE USER-INTERFACE MODIFICATIONS AND DESIGN MODIFICATIONS TO COMPENSATE FOR CHANGES IN ELECTRONIC COMPONENT AVAILABILITY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EXOGEN 4000+ BONE HEALING SYSTEM. THE EXOGEN 4000+ IS INDICATED FOR THE NON-INVASIVE TREATMENT OF ESTABLISHED NON-UNIONS EXCLUDING SKULL AND VERTEBRA. IN ADDITION, IT IS INDICATED FOR ACCELERATING THE TIME TO A HEALED FRACTURE, FOR FRESH, CLOSED, POSTERIORLY DISPLACED DISTAL RADIUS FRACTURES AND FRESH, CLOSED OR GRADE I OPEN TIBIAL DIAPHYSIS FRACTURES IN SKELETALLY MATURE INDIVIDUALS WHEN THESE FRACTURES ARE ORTHOPAEDICALLY MANAGED BY CLOSED REDUCTION AND CAST IMMOBILIZATION.
-
-