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Description
Its a two-pronged approach: fix the mechanical problem and protect the affected nerves
We are also making conforming regulation text changes at 484.375(b)(5)
Partial tears can occur from repetitive trauma or chronic tendonitis
Its possible that their definition of helpfulness differs from yours
Body weight may influence dosing for some compounds (especially weight-based dosing for FDA-approved indications)
Long-term human safety data are not yet established
