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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 Lyft with Lidocaine
Classification Nameimplant, dermal, for aesthetic use in the hands
Generic Nameimplant, dermal, for aesthetic use in the hands
Applicant
Q-Med AB
seminariegatan 21
uppsala SE-75-752-
PMA NumberP040024
Supplement NumberS099
Date Received08/29/2017
Decision Date05/18/2018
Product Code
PKY[ Registered Establishments with PKY ]
Docket Number 18M-1970
Notice Date 05/22/2018
Advisory Committee General & Plastic Surgery
Clinical Trials NCT02650921
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the Restylane Lyft with Lidocaine for expanding the indications to include injection into the subcutaneous plane in the dorsal hand to correct volume deficit 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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