PMA P050033S008
- Device
- ELEVESS
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P050033
- Supplement
- S008
- Product code
- LMH
- Decision date
- 2010-05-24
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- APPROVAL FOR REVISION OF THE PHYSICIAN AND PATIENT LABELS TO INCLUDE UPDATES ON THE POST MARKET ADVERSE EVENT EXPERIENCE WITH THE DEVICE.
Current openFDA PMA Record#
- Device
- ELEVESS
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P050033
- Supplement
- S008
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2010-05-24
- Decision code
- APPR
- Date received
- 2009-09-08
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR REVISION OF THE PHYSICIAN AND PATIENT LABELS TO INCLUDE UPDATES ON THE POST MARKET ADVERSE EVENT EXPERIENCE WITH THE DEVICE.