|
Device | SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2000 |
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 | S003 |
Date Received | 01/02/1996 |
Decision Date | 03/27/1997 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) MODEL 2000(TM). |