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

P080012

Protocol Approved

05/03/2012

Study Name

Prometra Programmable Pump system

Study Status

Study Pending

General Study Protocol Parameters

Study Design

Prospective Cohort Study

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

Yes

Data Source

Sponsor Registry

Comparison Group

No Control

Analysis Type

Analytical

Study Population

Adult: >21

Detailed Study Protocol Parameters

Study Design Description

Prospective, non-randomized, open-label, multicenter study

Study Population Description

Group A: Active prospective study subjects.

Group B: Subjects previously enrolled in the premarket trials PUMP

I or PUMP II will be offered voluntary participation in the post-approval study. Subjects in Group B will be followed for a total of five years, which includes all time enrolled in the previous PUMP study.

 

Sample Size

400 patients

Data Collection

Primary endpoint is to assess long-term occurrence and safety as a result of granuloma formation.



Secondary

endpoints are to assess the long-term device performance including: Pump failure, including time to occurrence, type, and number of occurrences; and pump battery life.

 

Followup Visits and Length of Followup

5 years

Subjects shall be seen at least once every 90 days (± 30 days) from

the date of implantation (Group A) or enrollment (Group B) throughout the study

 

Prometra Programmable Pump system Schedule

Report Schedule	Report Date Due	FDA Receipt Date	Reporting Status
six month report	08/07/2012	07/24/2012	On Time
one year report	02/06/2013	02/06/2013	On Time
18 month report	08/07/2013
two year report	02/06/2014
three year report	02/04/2015
four year report	02/06/2016
five year report	02/05/2017
six year report	02/05/2018

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