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(INJECTABLE GELS) |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB SEMINARIEGATAN 21 UPPSALA SE-75-752- |
PMA Number | P040024 |
Supplement Number | S079 |
Date Received | 02/12/2015 |
Decision Date | 01/26/2016 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Review Memo | Review Memo |
Approval Order Statement APPROVAL FOR A NEW SYRINGE CONTAINER CLOSURE SYSTEM FOR RESTYLANE®, RESTYLANE-L®, PERLANE®, PERLANE-L® AND RESTYLANE® SILK. |
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