|
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 | S014 |
Date Received | 12/07/2001 |
Decision Date | 11/18/2002 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR LABELING CHANGES TO THE PHYSICIAN'S INSTRUCTIONS FOR USE. |