PMA P050047S042
- Device
- JEVEDERM HYALURONATE GEL IMPLANTS
- Applicant
- Allergan
- PMA number
- P050047
- Supplement
- S042
- Product code
- LMH
- Decision date
- 2014-11-19
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- APPROVAL FOR THE STRENGTHENING OF THE CURRENT WARNING AND THE DISCUSSION OF THE POTENTIAL ADVERSE REACTION(S) ASSOCIATED WITH VASCULAR INJECTION.
Current openFDA PMA Record#
- Device
- JEVEDERM HYALURONATE GEL IMPLANTS
- Applicant
- Allergan
- PMA number
- P050047
- Supplement
- S042
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2014-11-19
- Decision code
- APPR
- Date received
- 2014-11-03
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE STRENGTHENING OF THE CURRENT WARNING AND THE DISCUSSION OF THE POTENTIAL ADVERSE REACTION(S) ASSOCIATED WITH VASCULAR INJECTION.