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 INJECTABLE GEL |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB SEMINARIEGATAN 21 SE-752 28 UPPSALA SE-75-752- |
PMA Number | P020023 |
Supplement Number | S004 |
Date Received | 04/05/2004 |
Decision Date | 05/05/2004 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF A 1 ML VIAL SIZE FOR THE RESTYLANE INJECTABLE GEL. |
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