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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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Neurotoxicity/Carcinogenicity


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General
Study Status Completed
Application Number /
Requirement Number		 P960009 / PAS001
Date Original Protocol Accepted 04/16/2010
Date Current Protocol Accepted 04/16/2010
Study Name Neurotoxicity/Carcinogenicity
Device Name MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM
General Study Protocol Parameters
Study Design Bench/Lab Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This is a lab study with the following objectives: (1) to extract Pellethane 80A and Elasthane 80A devices under aqueous conditions (phosphate buffered saline containing bovine serum albumin) and quantify 4, 4' methylene dianiline (MDA) in the extracts at particular timed intervals. Other target compounds will include ethylenediamine, butanediol, and tin. Target analytes will be quantified against standard curves of each analyte. (2) to determine extractable levels of 4, 4' methylene dianiline (MDA) by weight in Pellethane 80A used in the Model 3387 and 3389 DBS tremor lead. The testing is performed on Pellethane 80A as prepared for intended device use. The test is an exhaustive extraction. Two extraction media, isopropyl alcohol (IPA) and acetonitrile (ACN), are used.
Study Population N/A
Sample Size N/A
Key Study Endpoints See study description
Follow-up Visits and Length of Follow-up N/A


Neurotoxicity/Carcinogenicity Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Annual Report 09/30/2008 09/30/2008 On Time
6 month report 10/15/2010 10/15/2010 On Time
1 year report 04/16/2011 04/13/2011 On Time
18 month report 10/15/2011 10/17/2011 Overdue/Received
2 year report-FINAL REPORT 04/15/2012 04/17/2012 Overdue/Received


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

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