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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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OSB Lead-PRESTIGE LP 2-Level Metal Concentrations


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General
Study Status Progress Inadequate
Application Number P090029 S003/ PAS002
Study Name OSB Lead-PRESTIGE LP 2-Level Metal Concentrations
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description A one-arm cohort study
Study Population Description Patients diagnosed with degenerative disc disease at two (2) contiguous levels in the cervical spine from C3 to C7 and implanted with Prestige LP
Sample Size 30
Data Collection The main study end-point is assessment of metal concentrations (titanium, vanadium, and aluminum) and their changes over time in blood serum.

Additional Study endpoints are as follows:

Overall success rate with overall success defined as:

NDI score improvement of at least 15 points from baseline at

Maintenance or improvement in neurological status

No serious AE classified as implant associated/related or implant/surgical procedure associated/related

No secondary surgical procedure classified as a treatment “failure”

o Neck Disability Index (NDI) score improvement from baseline;

o Neurological Status change from baseline

o Neck and Arm Pain score change from baseline

o Safety of the PRESTIGE LP™ Cervical Disc as reported through AEs and secondary surgeries.
Follow-up Visits and Length of Follow-up 24 months


OSB Lead-PRESTIGE LP 2-Level Metal Concentrations Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 01/05/2017 12/20/2016 On Time
one year report 07/07/2017 07/03/2017 On Time
18 month report 01/05/2018    
two year report 07/07/2018    
three year report 07/07/2019    
four year report 07/06/2020    
five year report 07/06/2021    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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