PMA P050047S022

Device: JUVEDERM HYALURONATE
Applicant: Allergan
PMA number: P050047
Supplement: S022
Product code: LMH
Decision date: 2012-02-24
Classification: Implant, Dermal, For Aesthetic Use
Generic name: Implant, dermal, for aesthetic use
Approval order statement: APPROVAL FOR THE ADDITION OF A NEW PRECAUTION STATEMENT: FAILURE TO COMPLY WITH THESE INSTRUCTIONS COULD RESULT IN NEEDLE DISENGAGEMENT AND/OR PRODUCT LEAKAGE AT TE LUER-LOCK NEEDLE HUB CONNECTION.

Current openFDA PMA Record#

Device: JUVEDERM HYALURONATE
Applicant: Allergan
PMA number: P050047
Supplement: S022
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2012-02-24
Decision code: APPR
Date received: 2012-01-25
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE ADDITION OF A NEW PRECAUTION STATEMENT: FAILURE TO COMPLY WITH THESE INSTRUCTIONS COULD RESULT IN NEEDLE DISENGAGEMENT AND/OR PRODUCT LEAKAGE AT TE LUER-LOCK NEEDLE HUB CONNECTION.