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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Devicesaypha® MagIQ™
Generic NameImplant, dermal, for aesthetic use
ApplicantCroma-Pharma GmbH
Industriezeile 6
Leobendorf 2100
PMA NumberP240008
Date Received03/27/2024
Decision Date09/08/2025
Product Code LMH 
Docket Number 25M-3655
Notice Date 09/09/2025
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT03990883
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for saypha® MagIQ™ for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults over the age of 21.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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