|
Device | EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) |
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 | S028 |
Date Received | 07/20/2007 |
Decision Date | 08/16/2007 |
Product Code |
LPQ |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN THE MANUFACTURE OF THE EXOGEN 4000+ DEVICE TO A CONTINUOUS FLOW MANUFACTURING MODEL AND A CHANGE IN THE SERIAL NUMBERING SCHEME OF THE DEVICE. |