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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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Device Exposure Registry Study

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Study Status Redesigned/Replaced Study
Application Number /
Requirement Number
P130004 / PAS001
Date Original Protocol Accepted 01/08/2014
Date Current Protocol Accepted 05/05/2020
Study Name Device Exposure Registry Study
General Study Protocol Parameters
Study Design Retrospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives The objective of this study is to collect post-approval data relative to the incidence of endophthalmitis (within 30 days) for cataract surgery patients treated with the ReSure Sealant when used by a broad group of physicians under commercial use conditions.

This study is designed as a retrospective, multicenter, observational, single- arm post-approval registry study that will include up to 100 US centers and will enroll at least 4857 patients treated with ReSure Sealant.
Study Population The study population is defined as all patients who receive at least one application of the ReSure Sealant on the operative eye in 2014 or 2015 (up to October 2015).
Sample Size A sample of 4857 patients provides approximately 82% power (alpha = 0.05) to detect a difference (P1 – P0) of -0.0020, using a one-sided binomial test, where P0 is the proportion of endophthalmitis within 30 days under the null hypothesis (0.0040) and P1 is the proportion of endophthalmitis within 30 days under the alternative hypothesis (0.0020).

The results assume that the population proportion under the null hypothesis is 0.0040.
Key Study Endpoints The primary endpoint will be the occurrence of endophthalmitis (based on
the ‘specific’ definition) within 30 days (±10 days) of the cataract procedure.

Endophthalmitis is defined (i.e., sensitive definition) to have occurred if at least one of the ICD-9-CM or ICD-10-CM codes listed belowhas been reported.

Endophthalmitis is defined (i.e., specific definition) to have occurred if at least one of the ICD-9-CM or ICD-10-CM codes listed below has been reported and at least one of the CPT-4/HCPCS procedure codes listed below has been reported.

ICD-9-CM Codes:
360.0 – purulent endophthalmitis
360.00 – unspecified purulent endophthalmitis
360.01 – acute endophthalmitis
360.02 – panophthalmitis
360.03 – chronic endophthalmitis
360.04 – vitreous abscess
364.03 – secondary iridocycitis, infectious

CPT-4 / HCPCS Procedure Codes:
CPT-4: 66030 – injection of medication in anterior chamber
CPT-4: 67005/67010 – anterior vitrectomy
CPT-4: 67028 – intravitreal injection of pharmacologic agent
CPT-4: 67036 – pars plana vitrectomy
Follow-up Visits and Length of Follow-up As a retrospective study, there is technically no follow-up. The study is designed primarily to ascertain if Medicare patients treated with ReSure Sealant were diagnosed with endophthalmitis within 30 days of cataract surgery. Patients from the Clinical PAS will be pooled into this study with the outcome reported through site/investigator record review.

Device Exposure Registry Study Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 07/09/2014 07/28/2014 Overdue/Received
one year report 01/08/2015 02/26/2015 Overdue/Received
18 month report 07/09/2015 07/08/2015 On Time
three year report 01/07/2017 02/01/2017 Overdue/Received
interim report 11/07/2017 11/07/2017 On Time
interim report 04/07/2018 05/02/2018 Overdue/Received
progress report 11/06/2018 11/06/2018 On Time
four year report 01/07/2019 11/21/2019 Overdue/Received
final Report 01/07/2021 01/06/2021 On Time

Contact Us

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

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