| 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. |
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| Device | Restylane®-L 1 mL; Restylane® Lyft™ with Lidocaine 1 mL; Restylane® Eyelight™ 0.5 mL |
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| Generic Name | Implant, dermal, for aesthetic use |
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| Applicant | Q-Med AB
Seminariegatan 21
Uppsala SE-752-28 |
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| PMA Number | P040024 |
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| Supplement Number | S143 |
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| Date Received | 07/02/2025 |
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| Decision Date | 01/29/2026 |
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| Product Code |
LMH |
| Advisory Committee |
General & Plastic Surgery |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
multiple changes including, (1) primary packaging, (2) a new needle and hub, (3) secondary packaging updates, (4) inclusion of a treatment card for recording patient and treatment information, (5) an updated IFU with updated needle assembly instructions adapted for the new syringe and the needle and information regarding the new treatment card, (6) a new syringe label, (7) a new semi-automatic downstream manufacturing line, and (8) a new transport box to fit the new smaller secondary packaging. |
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