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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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Sort By Application Number Application
Number		 Sort By Application Number -- Descending
Sort By Manufacturer Applicant Sort By Manufacturer -- Descending
   Sort By Device Name Device
Name		 Sort By Device Name -- Descending
Sort By Medical Specialty Medical
Specialty		 Sort By Medical Specialty -- Descending
Sort By Date Order Date PMA
Approved		 Sort By Date Order -- Descending
Study
Name
Study Status
P010031  S674 MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT Cobalt XT HF Quad CRT-D MRI SureScan (DTPA2QQ, DTPA2Q1); Cobalt XT HF CRT-D MRI SureScan (DTPA2D4 and DTPA2Dl); Cobalt HF Quad CRT-D MRI SureScan (DTPB2QQ and DTPB2Ql); Cobalt HF CRT-D MRI SureScan (DTPB2D4 and DTPB2Dl); Crome HF Quad CRT-D MRI SureScan (DTPC2QQ and DTPC2Q1); and Crome HF CRT-D MRI SureScan (DTPC2D4 and DTPC2Dl) Implantable Pulse Generators with Cardiac Resynchronization Therapy; and Cobalt Crome Application Software Model D00U005 Cardiovascular 04/23/2020 iATP PAS Ongoing


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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