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. |
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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 | S035 |
Date Received | 07/15/2013 |
Decision Date | 05/29/2014 |
Product Code |
LPQ |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A NEW BIOVENTUS MANUFACTURING FACILITY IN CORDOVA, TENNESSEE, MANUFACTURING PROCESS CHANGES, A RECHARGEABLE BATTERY AND CHARGER, REDESIGN OF THE MAIN OPERATING UNIT, CHANGES TO THE INSTRUCTIONS FOR USE, AND MODIFIED PACKAGING. |
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