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. |
|
Device | BELLAFILL |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Tiger Aesthetics Medical, LLC. 555 E North Ln. Suite 5000, Bldg. D Conshohocken, PA 19428 |
PMA Number | P020012 |
Supplement Number | S009 |
Date Received | 05/16/2014 |
Decision Date | 12/23/2014 |
Product Code |
LMH |
Docket Number | 14M-2376 |
Notice Date | 12/30/2014 |
Advisory Committee |
General & Plastic Surgery |
Clinical Trials | NCT00778531
|
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR THE BELLAFILL. THIS DEVICE IS 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 YEARS. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
|
|