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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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

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Study Status Study Pending
Application Number /
Requirement Number
P220004 / PAS001
Date Original Protocol Accepted 11/02/2023
Date Current Protocol Accepted  
Study Name PALMAZ MULLINS XD Real-World Use PAS
Device Name PALMAZ MULLINS XD Pulmonary Stent
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent A (distinctively) : 18-21 yrs
Detailed Study Protocol Parameters
Study Objectives Prospective, single-arm, multi-center, post-approval study of all consecutive subjects treated with the Palmaz Mullins XD Pulmonary Stent.
The objective of this study is to characterize clinical outcomes and to assess the real-world use of the commercial Palmaz Mullins XD Pulmonary Stent.
Study Population The study population will contain all consecutive subjects treated with the commercially available Palmaz Mullins XD Pulmonary Stent.

“Consecutive” is defined as a commitment by the participating investigators at each study site to enroll all subjects admitted for non-emergency
treatment of pulmonary artery stenosis who meet eligibility criteria per the IFU and are selected to receive the Palmaz Mullins XD Pulmonary Stent.
Sample Size Number of subjects: The study will enroll a minimum of 35 subjects and a maximum of 75 subjects or until the end of the 2-year enrollment period has been reached, whichever comes first.

Assumptions for sample size estimation: Sample size is based on assumed enrollment rate over a two year period.
Number of sites: Up to 11 sites
Sites location: In the United States
Key Study Endpoints Safety Endpoints
Primary: Device or procedure-related, serious adverse events reported through time of hospital discharge, which meet any of the following criteria:
a) Led to a death,
b) Led to a serious deterioration in health of the subject, that either resulted in
1. Life-threatening illness or injury, or
2. Hospitalization (initial or prolonged), or
3. Disability or permanent impairment of a body structure or a body function, or
4. Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function
c) Other Serious (important) Medical Events

Effectiveness Endpoints
Primary: Patency defined as an increase in stented vessel minimum pulmonary artery diameter by = 50% of the pre-stent diameter determined
by post-implant angiography.

Technical Success defined as:
1) Successful access, delivery and retrieval of the device delivery system,
2) Deployment and correct positioning of the device in the intended location, and
3) No need for additional, unplanned surgery or re-intervention related to the device or access procedure.
Follow-up Visits and Length of Follow-up Length of follow-up is through time of hospital discharge. There will not be follow-up visits after the patient is discharged following the implantation
procedure of the Palmaz Mullins Pulmonary Stent

PALMAZ MULLINS XD Real-World Use PAS Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
1 year report 07/20/2024    
2 year report 07/20/2025    
3 year report 07/20/2026    
4 year report 07/20/2027    

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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