ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT

{0}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Image /page/0/Picture/2 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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a bird-like figure with three wing-like shapes. DEC 15 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Danielle Alarcon Regulatory Affairs Specialist Advanced Neuromodulation Systems 6901 Preston Road Plano, Texas 75024 Re: K053250 : K053250 Trade/Device Name: ANS 3100 and 3200 series leads: 90 and 110 cm lengths Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted Spinal Cord Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZB Dated: November 18, 2005 Received: November 30, 2005 Dear Ms. Alarcon: We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section JTQ(x) premained is substantially equivalent (for the indications referenced above and have determined the devices marketed in interstate referenced above and have determined the devices marketed in interstate for use stated in the enclosure) to legally marketed predical Device Amendments for use stated in the enclosure) to regally manced produced Device Amendments, or to commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the enactinent and other of the Federal Food. Drug, devices that have been reciassified in accondited approval approval application (PMA). and Cosmetic Act (Act) that do not require approval assessment of the Act The and Cosmetic Act (Act) that do not require approvate of the general controls provisions of the Act. The You may, therefore, market the device, subject to the general const You may, therefore, market the ucvice, subject to annual registration, listing of general controls provisions of the Act include required withistras accing and general controls provisions of the Act mende requirement. 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 (PMA), it If your device is classified (see above) nito ennier caso if expecularies) affecting your device can may be subject to such additional controls. Existing major regulations a may be subject to such additional controlist Existing major be found in the Code of I cacral regarations) publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s Issualitat of a substination with other requirements of the Act that FDA has made a determination that your device after clongencies You must that I'DA has made a determination that your devies somplet Federal agencies. You must {1}------------------------------------------------ Page 2 - Ms. Danielle Alarcron comply with all the Act's requirements, including, but not limited to: registration and listing (21 comply with an this fier of 1 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation of to begin marketing your device as described in your Section 510(k) I mis lotter will and in your he FDA finding of substantial equivalence of your device to a legally premailed predicated device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, N Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known): |< 0 S 3 2 SO Device Name: ANS 90 cm and 110 cm (3100 and 3200 Series) Lead Kit Indications For Use: Advanced Neuromodulation Systems 90 cm and 110 cm (3100 and / lovanood Noaromouth ate indicated for the management of chronic pain of 5200 Ochool) Eoda Reither as the sole mitigating agent, or as an adjunct to the trank and limber of the a multidisciplinary approach and are other model of therapy addition Systems receivers, IPGs, transmitters, and/or antennae. | Prescription Use _X_ | Or | |----------------------|------------------------| | (Per 21 CFR 801.109) | Over-The-Counter Use _ | (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, office of Device Evaluation (ODE) 2 (Division Sign-Off) Division of General, Restorative, and Neurological Devices **510(k) Number** K053250