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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Study Status Progress Adequate
Application Number P010012 S398/ PAS001
Date Current Protocol Accepted 07/07/2020
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source Admin Database
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The purpose of the MOUNTAIN PAS program is to provide a sustainable mechanism for the collection of data to assess the
short and long term performance of Boston Scientific BSC pacing and defibrillation leads. The data sources used to evaluate the ACUITY X4 lead include four existing Real-World Data (RWD) databases and one clinical trial database.
Study Population Description All patients added to each database (CMS, Device Tracking, LATITUDE, Complaints database) during the evaluation period will be included in the analyses as specified.
Sample Size Data from all US centers that contribute data to any of the databases will be used in the analysis.
Data Collection The sponsor states that the short-term safety and short- and long-term effectiveness objectives have already been fulfilled through evaluation of clinical trial data. The long-term safety objective has yet to be fulfilled and will be assessed by the Primary Safety Endpoint, Sensitivity Analysis and other analysis specified.
Follow-up Visits and Length of Follow-up Data will be collected during routine device follow-up and patient care. No additional follow-ups or procedures are required.
Interim or Final Data Summary
Interim Safety Information ACUITY X4: The overall complication-free rate is 97.6% for the ACUITY X4 lead at five years with a lower confidence limit of 97.3%.
RELIANCE 4-FRONT: The observed primary event-free rate for the RELIANCE 4-FRONT leads at 5 years equaled 99.6% with a lower confidence limit of 98.9%.
Actual Number of Patients Enrolled ACUITY X4: 34,210
Actual Number of Sites Enrolled N/A
Patient Follow-up Rate N/A
Study Strengths & Weaknesses The study is progressing as expected.


Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 08/22/2016 08/19/2016 On Time
1 year report 02/21/2017 02/21/2017 On Time
18 month report 08/22/2017 08/09/2017 On Time
2 year report 02/21/2018 02/12/2018 On Time
3 year report 02/21/2019 02/21/2019 On Time
4 year report 02/21/2020 02/21/2020 On Time
5 year report 04/30/2021 04/29/2021 On Time
6 year report 04/30/2022 04/28/2022 On Time
7 year report 04/30/2023    

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources