Post-Approval Studies

Post-Approval Studies

• In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
• The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
• CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
• In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.

Links

• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Webpage FAQs
• Tools for Conducting PAS
• Letter to IRB Chairs (formerly referred to as "IRB Letter from Dr. Schultz (dated 2/9/09)"
• Letter to PAS Participants
• Letter to PAS Investigators
• Post-Approval Studies Workshops
• Report on Implementation of Post-Approval Studies for Medical Devices Workshop (June 2009)

Contact Information

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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General

Application Number

P110010 S001

Protocol Approved

08/24/2012

Study Name

PROMUS Element Plus US PAS

Study Status

Progress Adequate

General Study Protocol Parameters

Study Design

Prospective Cohort Study

Study involve follow-up of premarket cohort (Y/N)

No

Data Source

New Data Collection

Comparison Group

Historical Control

Analysis Type

Analytical

Study Population

Transitional Adolescent A: 18-21 yrs, Adult: >21

Detailed Study Protocol Parameters

Study Design Description

Prospective, open-label, multi-center registry study

Study Population Description

PLATINUM-like patients, including at least 200 patients treated with PROMUS Element Plus long lesion stents

32/38 mm lengths (2.50-4.0mm diameters).

 

Sample Size

2,689 consecutive, consented patients from up to 65 sites in order to attain 906 PLATINUM

like patients from the US PAS (33.7% of the enrolled patients)

 

Data Collection

Primary: Cardiac death or myocardial infarction rate through 12 months post stent implantation among all

PLATINUM-like patients

Secondary: Stent thrombosis rate, longitudinal stent deformation, and PROMUS Element plus related MACE, cardiac death/MI, TVF, TVR, cardiac death, and MI.

 

Followup Visits and Length of Followup

5 years

30- days, 180-days, and annually through 5 years post intervention

PROMUS Element Plus US PAS Schedule

Report Schedule	Report Date Due	FDA Receipt Date	Reporting Status
3 month report	08/31/2012	09/20/2012	Overdue/Received
6 month report	11/30/2012	11/16/2012	On Time
9 month report	06/01/2013
one year report	06/01/2013
18 month report	11/30/2013
two year report	06/01/2014
three year report	06/01/2015
four year report	05/31/2016
five year report	05/31/2017

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