Juvéderm Gel Implants - P050047
This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Juvéderm 24HV, Juvéderm 30 & Juvéderm 30HV Gel Implants
PMA Applicant: Inamed Corporation
Address: 5540 Ekwill Street; Santa Barbara, California 93111
Approval Date: June 2, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050047a.pdf
What is it? The Juvéderm Implant is a hyaluronic acid gel that is injected into the middle layer of skin (mid to deep dermis) to temporarily correct moderate to severe facial wrinkles and folds (such as nasolabial folds).
How does it work? The Juvéderm Implants function by injecting the gel into areas around the facial wrinkle or fold to temporarily reduce its appearance.
When is it used? The Juvéderm Implants are injected when a patient wishes to have their doctor correct moderate to severe facial wrinkles and folds.
What will it accomplish? Juvéderm Implants will provide temporary improvement in wrinkle or fold severity.
When should it not be used? Juvéderm Implants should not be used in patients with severe allergies and a history of anaphylaxis or in patients with allergies to bacterial proteins.
Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p050047