|
Device | EVOLENCE COLLAGEN FILLER |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | COLBAR LIFESCIENCE LTD. 9 HAMENOFIM ST. HERZLIYA 46733 |
PMA Number | P070013 |
Supplement Number | S003 |
Date Received | 08/28/2008 |
Decision Date | 06/05/2009 |
Withdrawal Date
|
12/03/2010 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING CHANGES BASED ON THE ADDITIONAL CLINICAL 12 MONTH SAFETY AND EFFICACY DATA SUBMITTED TO EXTEND THE INITIAL 6 MONTH SAFETY AND EFFICACY DATA. |