|
Device | EXOGEN 2000+ LOW INTENSITY 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 | S017 |
Date Received | 03/03/2003 |
Decision Date | 04/22/2003 |
Product Code |
LPQ |
Advisory Committee |
Orthopedic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF A NEW CIRCUIT BOARD INSPECTION STEP FOR THE EXOGEN 2000+ DEVICE. |