|
Device | EXOGEN 2000/SONIC ACCELERATED FRACTURE 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 | S011 |
Date Received | 07/11/2000 |
Decision Date | 09/08/2000 |
Product Code |
LPQ |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A CHANGE IN THE CONDITIONS OF APPROVAL TO TERMINATE THE REQUIREMENT FOR A PRESCRIPTION REGISTRY. |