|
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 | S017 |
Date Received | 12/04/2017 |
Decision Date | 01/02/2018 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Modification of the Bellafill tray by adding: 1) a stop shelf in the molded tray at a slight diagonal orientation to align the plunger end of the syringes; and 2) a flange indentation for placement of each syringe flange. |