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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FDA warns Signal Medical on unapproved hip implants (MassDevice) the FDA warning etter. The FDA sends a warning letter to Signal Medical, flagging it for making unapproved changes to its MicroSeal hip implants. The fda flagged signal medical corp. for selling a hip implant after making changes that weren’t approved by the federal safety watchdog.
Texas Firm Draws FDA Warning Over Adulterated Device . Texas Firm Draws FDA Warning Over Adulterated Device . raps.org 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.
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Securities registered pursuant to Section 12(g) of the Exchange Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes .
The SurgiSilTM Perma Facial Implants are injection-molded (pre-formed) silicone implants with a hardness of 40 on the shore "00" scale. The SurgiSilTM Perma Facial Implants have a cylindrical shape with tapered ends. The implants will be provided in various sizes, with diameters of 2-6 mm and lengths of 50-75 mm.
WARNING: DISTANT SPREAD OF TOXIN EFFECT. Postmarketing reports indicate that the effects of BOTOX Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties.
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Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes No Indicate by check mark if the registrant is not required to file.
FDA warns Surgisil for unapproved facial implant marketing ACBS Tester/QA – Plano, Texas – ITJobPro.com Search and apply for the latest Tester jobs in Wylie, TX. Verified employers. Verified employers.