PMA P050033S013
- Device
- DERMAL FILLER PRODUCT HYDRELLE (ELEVESS)
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P050033
- Supplement
- S013
- Product code
- LMH
- Decision date
- 2012-03-09
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- APPROVAL FOR UPDATES TO THE APPROVED PRODUCT LABEL BASED ON THE RESULTS OF YOUR POST-APPROVAL CLINICAL STUDY.
Current openFDA PMA Record#
- Device
- DERMAL FILLER PRODUCT HYDRELLE (ELEVESS)
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P050033
- Supplement
- S013
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2012-03-09
- Decision code
- APPR
- Date received
- 2011-06-20
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR UPDATES TO THE APPROVED PRODUCT LABEL BASED ON THE RESULTS OF YOUR POST-APPROVAL CLINICAL STUDY.