In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
This study is a prospective, single쳌]arm, multicenter registry of subjects implanted with GTS100 stents. Subjects
will be followed for at least 3 months and up to 12 months from the date of implantation. The study will determine the rate of sight쳌]threatening adverse events for up to 6 months after surgery. The specific question this study will address is: What are the 3쳌]and 6쳌] month sight쳌]threatening adverse event rates after implanting the study device in conjunction with cataract surgery and the corresponding 95% confidence interval?
Study Population Description
Subjects with implantation of GTS100 in conjunction with cataract surgery.
Sight쳌]threatening adverse events
Followup Visits and Length of Followup
3 months or until adverse events related to the study procedure are resolved or stable,