|
Device | HYDRELLE |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Anika Therapeutics, Inc. 32 WIGGINS AVENUE BEDFORD, MA 01730 |
PMA Number | P050033 |
Supplement Number | S017 |
Date Received | 05/01/2014 |
Decision Date | 05/22/2014 |
Withdrawal Date
|
04/24/2023 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement TRANSFER OF RESIDUAL SOLVENT RELEASE TESTING FROM S&N LABORATORIES TO IN-HOUSE TESTING AT ANIKA THERAPEUTICS. |
Post-Approval Study | Show Report Schedule and Study Progress |