|
Device | OSTEOGEN IMPLANTABLE SPINAL FUSION 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 | S040 |
Date Received | 04/09/1998 |
Decision Date | 05/01/1998 |
Product Code |
LOE |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of a 8-cm mesh cathode to be used with the EBI OsteoGen(TM) Bone Growth Stimulator. |