1.9.2023 Board Book

St.louis MO 63108 7738202387 rooreddy@yahoo.com Application Review Links (Press "Ctrl" key and click link) Table of Contents I. Legal/COI II. FDA information III. Rationale/Code descriptor IV. Data collection V. Physician Services VI. Vignette-typical patient/description of procedure VII. Supporting Documentation / Literature VIII. Other Comments

II. FDA information II. 1 FDA Approval

If approval is necessary, have all devices and drugs necessary for performance of the procedure or service received FDA clearance or approval when such is required for performance of the procedure or service?

NOTE: All necessary FDA clearance or approval must be obtained prior to submission to the CPT Editorial Panel. No, some necessary element of the service has not received FDA approval or

clearance (Provide details) FDA approval isn't relevant.

2

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