|
Device | HYLAFORM PLUS (HYLAN B GEL) |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | GENZYME BIOSURGERY 55 CAMBRIDGE PARKWAY CAMBRIDGE, MA 02142 |
PMA Number | P030032 |
Supplement Number | S001 |
Date Received | 06/22/2004 |
Decision Date | 10/13/2004 |
Withdrawal Date
|
02/10/2016 |
Product Code |
LMH |
Docket Number | 04M-0467 |
Notice Date | 10/27/2004 |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Panel Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE HYLAFORM PLUS. 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 |