|
Device | EXOGEN ULTRASOUND BONE HEALING SYSTEM |
Generic Name | Stimulator, bone growth, non-invasive |
Applicant | BIOVENTUS LLC 4721 EMPEROR BLVD SUITE 100 DURHAM, NC 27703 |
PMA Number | P900009 |
Supplement Number | S041 |
Date Received | 12/13/2016 |
Decision Date | 01/12/2017 |
Product Code |
LOF |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Addition of a new rechargeable battery pack supplier for the EXOGEN Ultrasound Bone Healing System. |