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 | CervicalStim |
Generic Name | Stimulator, bone growth, non-invasive |
Applicant | Orthofix, Inc. 3451 Plano Parkway Lewisville, TX 75056 |
PMA Number | P030034 |
Supplement Number | S015 |
Date Received | 09/16/2019 |
Decision Date | 10/08/2019 |
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 Modify the manufacturing process for sewing the garment assembly for the Orthofix SpinalStim Model 5212 and modify the manufacturing process to cut, split, and strip the ribbon cable for the Orthofix CervicalStim Model 5505 and Orthofix PhysioStim Models 53XX. |
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