FDA Approvals - FDA Classifies Labeling Corrections Related To Occurrence Of Pocket Fills
FDA Classifies Labeling Corrections Related To Occurrence Of Pocket Fills During A SynchroMed(R) Implantable Infusion ...
Medtronic, Inc. (NYSE: MDT) announced that the U.S. Food and Drug Administration (FDA) has classified the corrections being made to product labeling in response to the occurrence of Pocket Fills during a drug refill of a SynchroMed II or SynchroMed EL Implantable Infusion Pump as a Class I recall. A Class I recall is a situation in which there is a reasonable probability that the use of, or ...