FDA warns Surgisil for unapproved facial implant marketing

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FDA has sent a warning letter to plastic and cosmetic surgery device maker Surgisil instructing the company to cease marketing two lip implant devices not indicated for that purpose, the agency disclosed Tuesday. Surgisil’s Perma Facial implant is cleared for use in plastic and reconstructive.

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The FDA this week released a warning letter it sent to cosmetic device maker Surgisil over unapproved marketing of its Perma Facial Implant.

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FDA has sent a warning letter to plastic and cosmetic surgery device maker Surgisil instructing the company to cease marketing two lip implant devices not. Surgisil's Perma Facial implant is cleared for use in plastic and reconstructive. of a second, unapproved device called the Perma Lip implant.

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The FDA this week released a warning letter it sent to cosmetic device maker Surgisil over unapproved marketing of its Perma Facial Implant device. The letter follows an inspection of the company.

FDA Warning Letter for Texas-Based Device Venture Over Adulterated Device. promotion of its Perma Facial Implant over an unapproved intended use.. Surgisil is marketing the product for an intended use not cleared by.

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In a new US Food and drug administration (fda) warning letter, Plano, TX-based Surgisil was urged to come into compliance with the marketing of its Perma Facial Implant over an unapproved intended use. FDA conducted an inspection of Surgisil’s operations, including its website, last September and.