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 | S008 |
Date Received | 07/28/2015 |
Decision Date | 08/26/2015 |
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 IMPLEMENTATION OF AN ALTERNATE MACHINE TO PRODUCE TRANSDUCER COILS (CERVICAL-STIM ONLY) AND REMOVE REDUNDANT INSPECTION OF VARIOUS DEVICE COMPONENTS. |
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