Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | EXOGEN 3000 |
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 | S008 |
Date Received | 10/27/1999 |
Decision Date | 04/14/2000 |
Product Code |
LPQ |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for various design and manufacturing changes which do not affect the output of the device. The device, as modified, will be marketed under the trade name Exogen 3000. |
|
|