Post-Approval Studies (PAS) Database

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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PMA Post-Approval Study

General
Study Status	Completed
Application Number / Requirement Number	P010030 S056/ PAS001
Date Original Protocol Accepted	12/17/2015
Date Current Protocol Accepted
Study Name	PMA Post-Approval Study
Device Name	LIFEVEST WEARABLE DEFIBRILLATOR
General Study Protocol Parameters
Study Design	Active Surveillance
Data Source	Sponsor Registry
Comparison Group	No Control
Analysis Type	Descriptive
Study Population	Child: 2-12 yrs, Adolescent: 13-18 yrs
Detailed Study Protocol Parameters
Study Objectives	Prospectively collect and assess device data with the patients under 18 years of age using manufacturer owned registry
Study Population	The patient population will be all patients who have been prescribed the LifeVest under the proposed indication. There are no comparison groups.
Sample Size	For the purpose of this data collection proposal, ZOLL will collect data on 150 patients under 18 years of age.
Key Study Endpoints	The following data will be collected: a) Patient Demographics: i. Age ii. Gender iii. ICD-9 code(s) describing the patient’s condition b) Performance: i. Daily compliance with use ii. Duration of use iii. Appropriate therapy delivery, as determined by internal medically trained personnel iv. ECG recordings during appropriate therapy delivery and any available description of the circumstances found within the Call Report Database. c) Safety: i. Inappropriate defibrillation therapy delivery, as determined by internal medically trained personnel ii. ECG recordings during inappropriate therapy delivery and any available description of the circumstances found within the Call Report Database iii. Adverse events reported to ZOLL through the customer support or technical support departments
Follow-up Visits and Length of Follow-up	The device will be used temporarily (days) and the data will be obtained from returned device. No actual patient followup is needed.
Interim or Final Data Summary
Actual Number of Patients Enrolled	273
Actual Number of Sites Enrolled	N/A
Patient Follow-up Rate	N/A
Final Safety Findings	Adverse event rate reported as complaints: - 4 (1.47% of patients) - 0.1 AEs/patient years of wear time (4/39.5) Inappropriate Defibrillation Data: 1 shock/14,435 patient days = 0.002 inappropriate shocks/month
Final Effect Findings	Only 1 appropriate shock was observed in the current study. First shock success rate: 100%.
Study Strengths & Weaknesses	N/A
Recommendations for Labeling Changes	Yes

PMA Post-Approval Study Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
final report	06/16/2016	06/14/2016	On Time
corrected final report	09/07/2016	09/07/2016	On Time

Contact Us

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

Additional Resources

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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background