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.
Transit. Adolescent B (as adults) : 18-21 yrs,
Detailed Study Protocol Parameters
Study Design Description
This is a non-randomized, open-label, observational study of patients treated with the RNS System.
Study Population Description
All patients implanted with the RNS Neurostimulator and/or Lead(s) who die and in whom it is
possible to obtain an autopsy , including patients in the LLT study and the RNS System PAS2 study, as well as non-study patients whose product data are tracked via the NeuroPace customer service and product monitoring systems.
A minimum of 15 autopsies must be conducted as part of the study
1. Data from autopsies obtained from any patient implanted with the Neurostimulator and Lead(s).
endpoint - additional data. Demographic and other data for each patient whose autopsy data are included in the primary endpoint