|
Device | HYDRELLE |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Anika Therapeutics, Inc. 32 WIGGINS AVENUE BEDFORD, MA 01730 |
PMA Number | P050033 |
Supplement Number | S007 |
Date Received | 05/15/2009 |
Decision Date | 06/01/2009 |
Withdrawal Date
|
04/24/2023 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN THE DEVICE NAME FROM ELEVESS TO HYDRELLE. |