|
Device | SONIC ACCELERATED FRACTURE HEALING SYSTEM/EXOGEN 3000 (TM) |
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 | S010 |
Date Received | 04/14/2000 |
Decision Date | 05/10/2000 |
Product Code |
LPQ |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change in the wording of the indication statement. |