|
Device | Bellafill Dermal Filter |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | SUNEVA MEDICAL, INC. 5879 PACIFIC CENTER BLVD. SAN DIEGO, CA 92121 |
PMA Number | P020012 |
Supplement Number | S013 |
Date Received | 03/06/2017 |
Decision Date | 04/06/2017 |
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 1) Changed contract test lab and associated SOP for residual monomer in unprocessed PMMA microspheres; 2) Changed contract test lab and associated SOP for residual monomer in processed non-sterile PMMA microspheres; and 3) Added reference to internal manufacturing document and clarified rejectcriteria for finished product specification. |