• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • Print
  • Share
  • E-mail

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.

Learn more...


OSB Lead-Continue F/u of Premarket Cohort

Suggest Enhancement / Report Issue | export reports to excelExport to Excel
Application Number P110021 / PAS001
Current Plan Approved 10/19/2012
Study Name OSB Lead-Continue F/u of Premarket Cohort
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
Final Study Results
Number of Patients 115
Number of Sites 25
Follow-up Rate 94.8%
Safety Findings At 5 year follow-up, the rates for major adverse events (in descending order) are all-cause mortality

65.8%, cardiovascular mortality 18.4%, reshospitalization 30.7%, bleeding (25.6%), major bleeding

21.0%, arterial vascular procedure 17.2%, major vascular complication 11.8%.

Effect Findings At 5 year follow-up, the mean values ± standard deviation for quality of life measures are:

KCCQ summary 69.1 ± 22.1, SF-12 Physical 34.9 ± 10.6, SF12 mental 52.2 ± 10.3, EQ-5D 0.7403 ± 0.2074.

Strengths & Weaknesses Strength: Longer-term (5-year) safety and effectiveness results are obtained and the device benefits over risks are sustained up to 5 years.

Weakness: smaller sample size, i.e. only 109 of the 115 eligible patients have completed the study follow-up. QoL follow-up rates at 3-5 years are low.

Label Changes Labeling update is not needed because Edwards Lifesciences LLC ceased US market distribution of the Edwards SAPIEN Transcatheter Heart Valve.

OSB Lead-Continue F/u of Premarket Cohort Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 04/19/2013 04/19/2013 On Time
one year report 10/19/2013 10/16/2013 On Time
18 month report 05/09/2014 05/06/2014 On Time
two year report 10/19/2014 10/15/2014 On Time
final report 10/19/2015 04/03/2015 On Time

Contact Us

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

Phone: (301) 796-6134
Fax: (301) 847-8140

Related Links