PMA P050033S014
- Device
- HYDRELLE
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P050033
- Supplement
- S014
- Product code
- LMH
- Decision date
- 2012-03-20
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- APPROVAL FOR ADDITION OF NEW SAFETY INFORMATION TO THE PRODUCT LABEL.
Current openFDA PMA Record#
- Device
- HYDRELLE
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P050033
- Supplement
- S014
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2012-03-20
- Decision code
- APPR
- Date received
- 2011-12-23
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR ADDITION OF NEW SAFETY INFORMATION TO THE PRODUCT LABEL.