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 | CERVICAL-STIM |
Generic Name | Stimulator, bone growth, non-invasive |
Applicant | Orthofix, Inc. 3451 Plano Parkway Lewisville, TX 75056 |
PMA Number | P030034 |
Supplement Number | S007 |
Date Received | 08/01/2014 |
Decision Date | 08/27/2014 |
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 PROCESS CHANGE FOR THE BONE GROWTH STIMULATOR DEVICES. |
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