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According to the official FDA premarket approval record for PMA P020012 supplement S009, which carries the decision date and the verbatim approval order statement for this device, supplement S009 was approved on December 23, 2014, and its approval order reads: indicated for the correction of nasolabial folds and moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21
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