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. |
|
Device | EXOGEN 2000+(TM) SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS(R)) |
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 | S013 |
Date Received | 04/30/2001 |
Decision Date | 09/04/2001 |
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 THE LOW INTENSITY ULTRASOUND FRACTURE TREATMENT SYSTEM-SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS(R)). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EXOGEN 2000+(TM) SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS(R)) AND IS INDICATED FOR THE NON-INVASIVE TREATMENT OF ESTBLISHED NONUNIONS* EXLUDING SKULL AND VERTEBRA. IN ADDITION, THE EXOGEN 2000+(TM) OR SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS(R)) IS INDICATED FOR ACCELERATING THE TIME TO A HEALED FRACTURE FOR FRESH, CLOSED, POSTERIORLY DISPLACED DISTAL RADIUS FRACTURES AND FRESH, CLOSED OR GRADE 1 OPEN TIBIAL DIAPHYSIS IN SKELETALLY MATURE INDIVIDUALS WHEN THESE FRACTURES ARE ORTHOPEDICALLY MANAGED BY CLOSED REDUCTION AND CAST IMMOBILIZATION. * A NONUNION IS CONSIDERED TO BE ESTABLISHED WHEN THE FRACTURE SITE SHOWS NO VISIBLY PROGRESSIVE SIGNS OF HEALING. |
|
|