|
Device | BELLAFILL |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | SUNEVA MEDICAL, INC. 5879 PACIFIC CENTER BLVD. SAN DIEGO, CA 92121 |
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 |
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 |
Post-Approval Study | Show Report Schedule and Study Progress |