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 | Bellafil 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 | S022 |
Date Received | 03/07/2018 |
Decision Date | 04/05/2018 |
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 | Yes |
Approval Order Statement Revise the secondary parameters for Bubble Point Filter Testing. |
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