|
Device | EXOGEN 2000+ BONE 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 | S023 |
Date Received | 05/15/2006 |
Decision Date | 06/30/2006 |
Product Code |
LPQ |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE INCORPORATION OF A DRI-SHIELD 2000 MOISTURE BARRIER BAG (ELECTROSTATIC DISCHARGE [ESD] BAG) AS PART OF THE DEVICE PACKAGING. |