CENTER FOR DRUG EVALUATION AND RESEARCH
Medical Device - Review
Referance : 4660463
Primary leachables stability study tested 3 ***** manufactured ****** lots. Data from samples under accelerated stability at 40°C/75% RH and at the intended storage condition (25°C/60% RH) from release to 6 months were provided with this resubmission. The Applicant noted testing through 36 months is ongoing.