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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Pinnacle CoMplete Acetabular Hip System


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General
Application Number P090002 / PAS001
Current Plan Approved 11/04/2011
Study Name Pinnacle CoMplete Acetabular Hip System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study design is a prospective, multi-center cohort study
Study Population Description The study population is comprised of patients implanted with the Pinnacle CoMplete Acetabular System.
Sample Size The sample size is 250 patients.
Data Collection The primary endpoint is device survivorship. The secondary objective is to evaluate five year cobalt and chromium median metal ion levels along with renal function indicators to include BUN levels and creatinine levels.
Follow-up Visits and Length of Follow-up 10 years.

Patients will receive clinical examination postoperatively at 4 weeks, 3 months, and 1, 2, 3,4, 5, 8, and 10 years. Patients will undergo radiographic examination at 4 weeks, and 1, 2, 3, 4, 5, 8, and 10 postoperative years. For patients in the metal ion study, metal ion testing and renal function testing will occur preoperatively and postoperatively at 1, 2, 5, 8, and 10 postoperative years.



Pinnacle CoMplete Acetabular Hip System Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/12/2011 12/09/2011 On Time
one year report 06/12/2012 06/14/2012 Overdue/Received
18 month report 12/11/2012 12/14/2012 Overdue/Received
two year report 06/12/2013 06/13/2013 Overdue/Received


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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