|
Device | EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATORS |
Generic Name | Stimulator, invasive bone growth |
Applicant | EBI, LLC 1 Gatehall Drive Suite 303 Parsippany, NJ 07054 |
PMA Number | P790005 |
Supplement Number | S053 |
Date Received | 11/19/2015 |
Decision Date | 12/17/2015 |
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 SUPPLIER FOR A MATERIAL USED IN THE DEVICE. |