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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.
 
DeviceRestylane Defyne
Generic Nameimplant, dermal, for aesthetic use
ApplicantQ-Med AB
seminariegatan 21
uppsala S-752-7522
PMA NumberP140029
Supplement NumberS027
Date Received06/16/2020
Decision Date01/29/2021
Product Code LMH 
Docket Number 21M-0153
Notice Date 02/05/2021
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT03624816
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for Restylane Defyne. The device is indicated for injection into the mid-to deep dermis (subcutaneous and/or supraperiosteal) for augmentation of the chin region to improve the chin profile in patients with mild to moderate chin retrusion over the age of 21.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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