|
Device | EVOLENCE COLLAGEN FILLER |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | COLBAR LIFESCIENCE LTD. 9 HAMENOFIM ST. HERZLIYA 46733 |
PMA Number | P070013 |
Date Received | 04/30/2007 |
Decision Date | 06/27/2008 |
Withdrawal Date
|
12/03/2010 |
Product Code |
LMH |
Docket Number | 08M-0402 |
Notice Date | 07/16/2008 |
Advisory Committee |
General & Plastic Surgery |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE EVOLENCE COLLAGEN FILLER, WHICH IS INDICATED FOR THE CORRECTION OF MODERATE TO DEEP FACIAL WRINKLES AND FOLDS SUCH AS NASOLABIAL FOLDS. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S005 |