PMA P050033S007
- Device
- HYDRELLE
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P050033
- Supplement
- S007
- Product code
- LMH
- Decision date
- 2009-06-01
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- APPROVAL FOR A CHANGE IN THE DEVICE NAME FROM ELEVESS TO HYDRELLE.
Current openFDA PMA Record#
- Device
- HYDRELLE
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P050033
- Supplement
- S007
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2009-06-01
- Decision code
- APPR
- Date received
- 2009-05-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A CHANGE IN THE DEVICE NAME FROM ELEVESS TO HYDRELLE.