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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.
 
DeviceMacroplastique Implants
Generic NameAGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
ApplicantUroplasty, LLC
5420 Feltl Rd.
Minnetonka, MN 55343
PMA NumberP040050
Supplement NumberS013
Date Received05/13/2022
Decision Date05/09/2023
Product Code LNM 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for modifying the labeling to reflect the findings of the Macroplastique Real-Time Observation of Safety and Effectiveness (ROSE) Registry.
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