|
Device | HYDRELLE |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Anika Therapeutics, Inc. 32 WIGGINS AVENUE BEDFORD, MA 01730 |
PMA Number | P050033 |
Date Received | 09/02/2005 |
Decision Date | 12/20/2006 |
Withdrawal Date
|
04/24/2023 |
Product Code |
LMH |
Docket Number | 06M-0531 |
Notice Date | 12/26/2006 |
Advisory Committee |
General & Plastic Surgery |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR THE COSMETIC TISSUE AUGMENTATION PRODUCT. THIS 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
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S011 S012 S013 S014 S015 S016 S017 S018 S019 S020 |