Implant, Dermal, For Aesthetic Use

Basic Information

• Device Name: Implant, Dermal, For Aesthetic Use
• Trade Name: Restylane Refyne, Restylane Defyne
• PMA Number: P140029
• Device Class: FDA Class 3
• Product Code: LMH
• Generic Name: Implant, dermal, for aesthetic use
• Medical Specialty: Unknown
• Advisory Committee: General, Plastic Surgery
• Decision: Approved
• Decision Code: APPR
• Decision Date: December 9, 2016
• Date Received: December 11, 2014
• Expedited Review: N
• Docket Number: 16M-4344

Advisory Committee Statement

Approval for Restylane Refyne is indicated for injection into the mid-to-deep dermis for the correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in patients over the age of 21. Restylane Defyne is indicated for injection into the mid-to-deep dermis for the correction of moderate to severe, deep facial wrinkles and folds (such as nasolabial folds) in patients over the age of 21.

Classifications

This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

Product Code	Device Name	Device Class	Medical Specialty
LMH	Implant, Dermal, For Aesthetic Use	FDA class 3	Unknown

Applicant

• Name: Q-Med AB
• Address: Seminariegatan 21, Uppsala, S-752, 7522