Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
DeviceBELLAFILL PMMA COLLAGEN DERMAL FILLER
Generic NameImplant, dermal, for aesthetic use
ApplicantSUNEVA MEDICAL, INC.
5879 PACIFIC CENTER BLVD.
SAN DIEGO, CA 92121
PMA NumberP020012
Supplement NumberS011
Date Received02/24/2015
Decision Date08/07/2015
Product Code LMH 
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT00778531
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR A CHANGE IN PRODUCT LABELING THAT DESCRIBED THE RESULTS OF YOUR 5-YEAR POST-APPROVAL STUDY (P521-01).
-
-