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Device | EBI 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 | S045 |
Date Received | 07/17/2008 |
Decision Date | 08/15/2008 |
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 ADDITION OF A CONFORMAL COATING ADHESIVE TO THE ELECTRONIC PRINTED CIRCUIT BOARDS OF THE DEVICE. |