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 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 | S015 |
Date Received | 09/01/2017 |
Decision Date | 09/28/2017 |
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 | No |
Approval Order Statement Removal of redundant quality control tests for SAN 8250 In-Process Tests with respect to PMMA. |
|
|