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Description

Seizures can occur in severe cases

To reduce bruising, apply gentle pressure (do not rub) for 10-15 seconds after injection, ice the site if needed, and be aware that blood thinners and supplements like fish oil increase bruising tendency

The final step is to label the vial with the date you reconstituted it and its concentration

Serious side effects are rare

Dries to a watertight, flexible rubberized coating that is waterproof and weatherproof, as well as mildew, chemical, and UV resistant

In response to the concern that the data provided did not compare the VersaVue TM Single-Use Flexible Cystoscope to other single-use, disposable cystoscopes, the applicant stated its belief that such evidence would not be relevant to this application, and that CMS did not explain why such evidence is necessary or how it could apply to the application under review