|
Device | HYDRELLE |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Anika Therapeutics, Inc. 32 WIGGINS AVENUE BEDFORD, MA 01730 |
PMA Number | P050033 |
Supplement Number | S016 |
Date Received | 05/01/2014 |
Decision Date | 07/17/2014 |
Withdrawal Date
|
04/24/2023 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR CHANGES TO THE STABILITY PROTOCOL. |
Post-Approval Study | Show Report Schedule and Study Progress |