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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DevicePALMAZ MULLINS XD Pulmonary Stent
Generic NamePulmonary stent
ApplicantCordis US Corp
14201 N.W 60th Ave.
Miami Lakes, FL 33014
PMA NumberP220004
Date Received04/11/2022
Decision Date07/21/2023
Product Code QWC 
Docket Number 23M-3903
Notice Date 09/18/2023
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the PALMAZ MULLINS XD Pulmonary Stent. The PALMAZ MULLINS XD Pulmonary Stent is indicated for the non-emergency treatment of pulmonary artery stenosis in pediatric patients who are at least 10kg in weight with two ventricle anatomy.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 
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