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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.
 
DeviceSurVeil Drug-Coated Balloon
Generic NameDrug-Eluting Peripheral Transluminal Angioplasty Catheter
ApplicantSurmodics,Inc.
9924 W. 74th St.
Eden Prairie, MN 55344
PMA NumberP210025
Date Received06/21/2021
Decision Date06/16/2023
Product Code ONU 
Docket Number 23M-3051
Notice Date 07/28/2023
Advisory Committee Cardiovascular
Clinical TrialsNCT03241459
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the SurVeil DCB. The device is indicated for use for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo or restenotic lesions (
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 
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