|
Device | EXOGEN 2000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) AND EXOGEN 3000 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 | S020 |
Date Received | 04/29/2005 |
Decision Date | 05/19/2005 |
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 ADDITION OF A NEW CONTRACT VENDOR FOR THE SUPPLY OF COMPONENTS/ MATERIALS USED IN THE MANUFACTURING PROCESS. |