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, RESTYLANE-L, PERLANE, PERLANE-L, RESTYLANE SILK |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB SEMINARIEGATAN 21 UPPSALA SE-75-752- |
PMA Number | P040024 |
Supplement Number | S083 |
Date Received | 08/31/2015 |
Decision Date | 12/15/2015 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR A NEW SUPPLIER OF RAW HYALURONIC ACID (HTLBIOTECHNOLOGY S.A.S., FRANCE). |
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