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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.
 
DeviceSurmodics SurVeil Drug-Coated Balloon
Generic NameDrug-Eluting Peripheral Transluminal Angioplasty Catheter
ApplicantSurmodics,Inc.
9924 W. 74th St.
Eden Prairie, MN 55344
PMA NumberP210025
Supplement NumberS003
Date Received04/11/2024
Decision Date07/02/2024
Product Code ONU 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for an alternate API supplier
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