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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSurVeil Drug-Coated Balloon
Generic NameDrug-Eluting Peripheral Transluminal Angioplasty Catheter
ApplicantSurmodics,Inc.
9924 W. 74th St.
Eden Prairie, MN 55344
PMA NumberP210025
Supplement NumberS006
Date Received02/26/2025
Decision Date06/06/2025
Product Code ONU 
Advisory Committee Cardiovascular
Clinical TrialsNCT03241459
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
inclusion of final post-approval study data in the labeling.
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