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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Devicesaypha® ChiQ™
Generic NameImplant, dermal, for aesthetic use
ApplicantCroma-Pharma GmbH
Industriezeile 6
Leobendorf 2100
PMA NumberP250021
Date Received06/26/2025
Decision Date06/12/2026
Product Code LMH 
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
saypha® ChIQ™ is indicated for use in cheek augmentation and restoring midface volume deficits in patients over the age of 21. The device is indicated to be administered by subcutaneous and/or supraperiosteal injection.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
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