Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | BIO OSTEOGEN SYSTEM |
Generic Name | Stimulator, bone growth, non-invasive |
Applicant | EBI, LLC a Highridge Medical Company 1 Gatehall Drive Suite 303 Parsippany, NJ 07054 |
PMA Number | P790002 |
Supplement Number | S027 |
Date Received | 08/11/2011 |
Decision Date | 09/07/2011 |
Product Code |
LOF |
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 REPLACEMENT OF AN ANALOG ELECTRICAL ISOLATION TESTER WITH A DIGITAL ELECTRONIC ISOLATION TESTER, AND ADDITION OF A MANUAL HAND-SOLDERING PROCESS AS AN ALTERNATIVE TO THE EXISTING AUTOMATIC SOLDERING PROCESS. |
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