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Device | SCULPTRA AND SCULPTRA AESTHETIC |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB SEMINARIEGATAN 21 UPPSALA SE-75-752- |
PMA Number | P030050 |
Date Received | 12/01/2003 |
Decision Date | 08/03/2004 |
Product Code |
LMH |
Docket Number | 04M-0350 |
Notice Date | 08/09/2004 |
Advisory Committee |
General & Plastic Surgery |
Expedited Review Granted? | Yes |
Combination Product | No |
Approval Order Statement APPROVAL FOR SCULPTRA. THE DEVICE IS INTENDED FOR RESTORATION AND/OR CORRECTION OF THE SIGNS OF FACIAL FAT LOSS (LIPOATROPHY) IN PEOPLE WITH HUMAN IMMUNODEFICIENCY VIRUS. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S024 S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 S051 S052 S053 |