|
Device | EBI OsteoGen™ Implantable Bone Growth Stimulators |
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 | S068 |
Date Received | 05/27/2022 |
Decision Date | 08/25/2022 |
Product Code |
LOE |
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 executing an ethylene oxide terminal sterilization process validation to align with applicable requirements of ISO 11135:2014 (14-529). |