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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 | S030 |
Date Received | 06/11/2019 |
Decision Date | 07/11/2019 |
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 Implement a modification to the existing environmental sampling and monitoring plan of the Company's ISO Class 7 and Class 8 Cleanrooms. |