|
Device | EXOGEN ULTRASOUND BONE HEALING SYSTEM |
Generic Name | Stimulator, ultrasound and muscle, for use other than applying therapeutic deep |
Applicant | BIOVENTUS LLC 4721 EMPEROR BLVD SUITE 100 DURHAM, NC 27703 |
PMA Number | P900009 |
Supplement Number | S036 |
Date Received | 08/22/2013 |
Decision Date | 05/07/2014 |
Product Code |
LPQ |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE IN CORDOVA, TENNESSEE. |