|
Device | HYLAFORM (HYLAN B GEL) |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | GENZYME BIOSURGERY 55 CAMBRIDGE PARKWAY CAMBRIDGE, MA 02142 |
PMA Number | P030032 |
Date Received | 08/01/2003 |
Decision Date | 04/22/2004 |
Withdrawal Date
|
02/10/2016 |
Product Code |
LMH |
Docket Number | 04M-0199 |
Notice Date | 05/05/2004 |
Advisory Committee |
General & Plastic Surgery |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE HYLAFORM. THE DEVICE IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS). |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S007 S008 S009 S010 S012 S013 S014 S016 S017 |