Company: Boston Scientific Corp.
Product: Investigational medical device
Date: 8/22/03

For example, the …and the …do not describe whether the monitor should verify all case histories and related documentation or only select a representative sample during the visit. If a sample is to be selected, the procedures do not state the size and composition of this sample. The procedures also should define what documentation will be maintained of telephone and electronic communication between the monitors and the clinical sites.

Issuer: Center for Devices and Radiological Health (CDRH)