|
Device | ARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT 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 | S012 |
Date Received | 02/24/2016 |
Decision Date | 04/21/2016 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes in the manufacturing process to remove a sampling step, split sterilization batch records, and add re-sieving steps. |