|
Device | Bellafill Dermal Filler |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | SUNEVA MEDICAL, INC. 5879 PACIFIC CENTER BLVD. SAN DIEGO, CA 92121 |
PMA Number | P020012 |
Supplement Number | S019 |
Date Received | 02/22/2018 |
Decision Date | 03/21/2018 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the improvement of the Instructions for Use to ensure that end users are aware that these medical devices should be stored in refrigerated conditions until ready to use. |