← Product Code [FTL](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTL) · K992991 # ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT (K992991) _Atrium Medical Corp. · FTL · Jan 27, 2000 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTL/K992991 ## Device Facts - **Applicant:** Atrium Medical Corp. - **Product Code:** [FTL](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTL.md) - **Decision Date:** Jan 27, 2000 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.3300 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use The Atrium Advanta™ PTFE Facial Implant is intended for use in Facial Plastic and Reconstructive Surgery. ## Device Story Atrium Advanta™ PTFE Facial Implant is a synthetic implant used in facial plastic and reconstructive surgery. Device serves as a scaffold for soft tissue augmentation or reconstruction. Implant is placed by a surgeon during a clinical procedure. Device provides structural support to facial tissues; benefits include restoration of contour or volume in reconstructive applications. No electronic components, software, or automated processing involved. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Polytetrafluoroethylene (PTFE) facial implant. Solid, biocompatible synthetic material. Non-resorbable. No energy source, connectivity, or software components. ## Regulatory Identification Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with stylized wings. Public Health Service JAN 27 2000 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Karen Hall RA/QA Manager Atrium Medical Corporation 5 Wentworth Drive Hudson, New Hampshire 03051 K992991 Re: > Trade Name: Atrium Medical Corporation Advanta™ PTFE Facial Implant Regulatory Class: II Product Code: FTL Dated: December 3, 1999 Received: December 6, 1999 Dear Ms Hall: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. {1}------------------------------------------------ Page 2 - Ms. Karen Hall If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Mail R.P. Ogden James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## INDICATIONS FOR USE STATEMENT | 510(k) Number (if known) | k992991 | |--------------------------|------------------------------------------------------------------------------------------------------------------------| | Device Name: | Atrium Advanta TM PTFE Facial Implant | | Indications for Use: | The Atrium Advanta TM PTFE Facial Implant is intended for use in Facial Plastic and Reconstructive Surgery. | ## PLEASE DO NOTY WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Prescription Use OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ NRO for JZD (Division Sign-Off) Division of General Restorative Devices K99299 510(k) Number Atrium Medical Corporation ... --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTL/K992991](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTL/K992991) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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