|
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 | S069 |
Date Received | 10/28/2022 |
Decision Date | 11/23/2022 |
Product Code |
LOE |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Qualify an alternate contract service provider to provide calibration services for instrumentation and lab equipment utilized to support manufacturing and quality operations. |