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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 NumberS002
Date Received02/01/2024
Decision Date02/29/2024
Product Code ONU 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
use of an alternative membrane filter for the preparation of intermediate drug materials in the manufacturing process
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