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 Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: EVOLENCE® Collagen Filler
PMA Applicant: ColBar LifeScience Ltd.
Address: 9 Hamenofim Street Herzlyia, 46733 Israel
Approval Date: June 27, 2008
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf7/p070013a.pdf
What is it? Evolence® Collagen Filler is a sterile, injectable, biodegradable, yellowish, opaque gel that is injected into the inner layers of facial skin (mid to deep dermis) in order to correct moderate to deep facial wrinkles and folds such as those around the nose and mouth (nasolabial folds).
How does it work? The EVOLENCE® Collagen Filler functions as a filler material which is injected into the appropriate area of the face in order to reduce the appearance of the wrinkle or fold.
When is it used? The EVOLENCE® Collagen Filler is injected when the patient wishes to have their physician correct moderate to severe facial wrinkles and folds.
What will it accomplish? The EVOLENCE® Collagen Filler will provide a temporary improvement in facial wrinkle or fold severity.
When should it not be used? The EVOLENCE® Collagen Filler should not be used in patients with a known hypersensitivity to any collagen products or porcine products, or patients with a history of severe allergies.
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=p070013