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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database

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The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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Explant Analysis


 
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General
Study Status Progress Inadequate
522 Number / Requirement Number PS110038 / PSS002
Date Current Plan Accepted 09/28/2012
Study Name Explant Analysis
Root Document Number K073413  K080991  K070359  K003523  K082239  K040627  K093646  K083642  K002883  K023786  K062426  K090998  K073570  K070554  K042992  K061221  K082585 
General Study Protocol Parameters
Study Design Other Study Design
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 This is an explant analysis study. Explanted devices will be retrieved from Pinnacle and ASR patients participating in 522 investigations and from patients outside of the 522 study whose surgeons agreed to follow protocol defined steps for retrieval and analysis.

Study Population Description Explanted devices from patients who received the Pinnacle or ASR in the post-market environment.

Sample Size Consecutive available devices for retrieval will be enrolled.

Data Collection Modes and causes of implant failure

Follow-up Visits and Length of Follow-up Not applicable. This is an analysis of explanted devices.



Explant Analysis Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 04/29/2013 04/29/2013 On Time
1 year report 10/31/2013 11/06/2013 Overdue/Received
18 month report 03/31/2014 04/02/2014 Overdue/Received
2 yr report 04/30/2015 04/30/2015 On Time
3 yr report 04/30/2016 04/29/2016 On Time
final report 03/28/2017 03/28/2017 On Time


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