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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSCULPTRA AESTHETIC
Classification Nameimplant, dermal, for aesthetic use
Generic Nameinjectable poly-l-lactic acid
ApplicantVALEANT INTERNATIONAL BERMUDA
PMA NumberP030050
Supplement NumberS014
Date Received12/20/2012
Decision Date05/28/2013
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the revision of a precaution statement in your product label to state: sculptra aesthetic should only be used by a healthcare practitioner trained to correct shallow to deep nasolabial contour deficiencies and other facial wrinkles, in which deep dermal grid pattern (cross-hatch) injection technique is appropriate, after the healthcare practitioner is fully familiar with the product, was, product educational materials, and the entire package insert and patient labeling. The device, as modified, will be marketed under the trade name sculptra aesthetic and is indicated for use in immune-competent people as a single regimen for correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles in which deep dermal grid pattern (cross-hatch) injection technique is appropriate.
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