|
Device | EXOGEN 4000+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 | S027 |
Date Received | 07/10/2007 |
Decision Date | 08/16/2007 |
Product Code |
LPQ |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES IN INTERNAL DEVICE CIRCUITRY AS MITIGATION AGAINST KNOWN DEVICE FAILURE MECHANISMS WHICH DO NOT IMPACT UPON ULTRASOUND OUTPUT OR SIGNAL PARAMETERS. |