|
Device | ORTHOGEN/OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR |
Generic Name | Stimulator, invasive bone growth |
Applicant | EBI, LLC a Highridge Medical Company 1 Gatehall Drive Suite 303 Parsippany, NJ 07054 |
PMA Number | P790005 |
Supplement Number | S047 |
Date Received | 04/08/2011 |
Decision Date | 05/06/2011 |
Product Code |
LOE |
Advisory Committee |
Orthopedic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MANUFACTURING CHANGES INVOLVING THE VERIFICATION OF ALCOHOL STERILITY AND THE MAGNET OVERRIDING TEST FIXTURE. |