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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® Kysse
Generic Nameimplant, dermal, for aesthetic use
Applicant
Q-Med AB
seminariegatan 21
uppsala S-752-7522
PMA NumberP140029
Supplement NumberS021
Date Received09/03/2019
Decision Date03/26/2020
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for Restylane Kysse. The device is intended for injection into the lips for lip augmentation and for correction of upper perioral rhytids in patients over the age of 21.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
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