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. |
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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 | S037 |
Date Received | 02/10/2021 |
Decision Date | 06/08/2021 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for change in secondary packaging tray lid material for the Bellafill Dermal Filler Treatment Kit and the Skin Test Kit, and change in co-packaged needle to TSK Steriject 27G Thin Wall needle for the Bellafill Dermal Filler Treatment Kit. |
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