FDA Premarket submission is not required for this device. Boston Scientific Neuromodulation operates globally. Parkinson’s Disease Foundation. Global Unique Device ID: 08714729905325. At least one of the products in the combination product must be a device in this case. The worst rep. imaginable in Arizona. 3. This information may 1) be on a label attached to a durable device, 2) be on a package of a disposable device, or 3) appear in labeling materials of an implantable device. Indicates that the device requires sterilization prior to use. Tremor and Other Hyperkinetic Movements, 4, 259. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4137360/#. How Many People in the USA Have Essential Tremor? The Vercise™ Primary Cell (PC) and Vercise Gevia™ Deep Brain Stimulation (DBS) Systems leverage the Vercise Cartesia™ Directional Lead to control the symptoms of Parkinson’s disease through highly personalized therapy. This number/code is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeleing, distribution and use to be determined. Because Parkinson’s disease is progressive, it’s critical to provide therapy that evolves with the patient. Boston Scientific can help you maximize your patients’ chances for successful therapy with mySCS™. Neuropathic pain: an overview. Name of the common device type associated with the GMDN Preferred Term Code/FDA PT Code. Organization accredited by FDA to operate a system for the issuance of UDIs. That’s why we’re dedicated to working closely with both physicians and patients to develop meaningful, industry-leading solutions that can improve the quality of life for millions worldwide. Deriving a Population Estimate Based on Epidemiological Data. If you think somebody is violating your copyrights and want to notify us, you can find information Only applicable to devices not subject to the requirements under 21 CFR 801.437. Accessed March 25, 2016. Choosing 'Yes' indicates that the device label or packaging contains one of the following statements: (1) "Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions", (2) This Product Contains Dry Natural Rubber", (3) Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions" or (4) "The Packaging of This Product Contains Dry Natural Rubber". Eight individually controlled electrodes on each lead allow physicians to adjust the range, shape, position and direction of electrical stimulation, which can reduce unwanted side effects and be adapted for continued symptom relief as Parkinson’s disease progresses. Featured stories and the latest news on what it takes to advance science for life, Pain relief made personal - Karen's story. The date by which the label of a device states the device must or should be used. Indicates storage and handling requirements that are required for the device including temperature, humidity, and atmospheric pressure. The Donation Identification Number is applicable to devices that are also regulated as HCT/Ps and is a number that is assigned to each donation. The Company offers forceps, guidewires, imaging systems, laser fibers, leads, needles, clips, atherectomy systems, catheters, stents, and definrillators. Eight individually controlled electrodes on each lead allow physicians to adjust the range, shape, position and direction of electrical stimulation, which can reduce unwanted side effects and be adapted for continued symptom relief as Parkinson’s disease progresses. Indicates the high value for storage and handling requirements. Pain Medicine, Volume 10, Issue 6, pages 972–1000, September 2009. ©2020 Boston Scientific Corporation or its affiliates. https://www.theacpa.org/uploads/documents/Partners%20for%20Understanding%20Pain%20Electronic%20Press%20Kit1.pdf. We respond to notices of alleged copyright infringement and terminate accounts of repeat infringers Boston Scientific Neuromodulation Corporation is located in Valencia, CA, United States and is part of the Electromedical, Electrotherapeutic & X-Ray Apparatus Manufacturing Industry. Additional undefined device size not represented in the GUDID Size Type LOV. Indicates the low value for storage and handling requirements. World Headquarters 300 Boston Scientific Way Marlborough, MA 01752-1234 Tel: +1 (800) 876-9960 Tel: +1 (508) 683-4000 Not all medical products that are NOT made with natural rubber latex will be marked. 2. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. This webpage represents 1508887662 NPI record. Kits are a collection of products, including medical devices, that are packaged together to achieve a common intended use and is being distributed as a medical device. Neuromodulation We understand that chronic pain and neurological diseases can be debilitating for patients. 1 Nunley, et al. Boston Scientific Neuromodulation operates globally. How Boston Scientific is Responding to the COVID-19 Pandemic. This number is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeleing, distribution and use to be determined. The National Academies Press, 2011. Please see the ASTM F2503-13 standard for more information. Accessed March 28, 2016. Each patient’s needs are unique and personal, which is why physicians need customizable treatment solutions. Boston Scientific Corporation Neuromodulation Grant Committee Attn: Grant Coordinator 25155 Rye Canyon Loop Valencia, CA 91355 661-949-4557 bsn.grants@bsci.com. FOUNDED. Completed applications for Boston Scientific Neuromodulation grants and donations are reviewed monthly by Boston Scientific grant review committees. Copyright © 2007-2020. ©2020 Boston Scientific Corporation or its affiliates. https://www.nap.edu/read/13172/chapter/2. Boston Scientific makes a spinal cord machine called the Precision Spectra Freelink Technology. Indicates that the device requires a prescription to use. NPI record contains FOIA-disclosable NPPES health care provider information. Take action in addressing health inequities in your community. Indicates that the device is a convenience, combination, in vitro diagnostic (IVD), or medical procedure kit. All rights reserved. Definition of the common device type associated with the GMDN Preferred Term Code/FDA PT Code. Numeric value for the clinically relevant size measurement of the medical device. The unit of measure associated with each clinically relevant size. There is no one-size-fits-all treatment for pain and neurological diseases, such as Parkinson’s Disease. This mobile app is designed to provide simple progress tracking during a Boston Scientific SCS trial, personalized goal setting, real-time support, and a summary … https://www.pdf.org/en/parkinson_statistics. 25155 Rye Canyon Loop The date on which a device is manufactured. That’s why we designed the Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System to provide personalized, long-lasting pain relief through the power of combination therapy, the technology of novel sub-perception algorithms and the simplicity of wave for automation. ADDRESS. The catalog, reference, or product number found on the device label or accompanying packaging to identify a particular product. 2. https://www.cdc.gov/features/arthritis-quality-life/index.html, 3. https://www.apdaparkinson.org/article/parkinsons-disease-prevalence-study/, Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. Advancing Deep Brain Stimulation. Pain is personal. 1. Boston Scientific Neuromodulation Corporation has 588 total employees across all of its locations and generates $92.78 million in sales (USD). RFA is a versatile outpatient procedure that is often used prior to SCS in the treatment continuum for chronic pain and has a more than 50-year track record of providing relief for patients with chronic pain. This date is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeleing, distribution and use to be determined. https://books.nap.edu/openbook.php?record_id=13172&page=1 This number is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeleing, distribution and use to be determined. The 1508887662 NPI number is assigned to the healthcare provider “BOSTON SCIENTIFIC NEUROMODULATION CORPORATION”, practice location address at “25155 RYE CANYON LOOP VALENCIA, CA, 91355-5004”. 2017:12 1409 – 1717. ii https://www.medtronic.com/us-en/healthcare-professionals/products/neurological/deep-brain-stimulation-systems/activa-rc.html | Accessed 08SEP2017. PAIN MEDICINE POSITION PAPER. 4 Reviews (661) 295-5718 Website. We understand that chronic pain and neurological diseases can be debilitating for patients. The number assigned to one or more device(s) that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits. Health Care Supplies. Company name associated with the labeler DUNS Number entered in the DI Record. Indicates the method(s) of sterilization that can be used for this device prior to device use on the patient. Phone number for the Customer contact; to be used by patients and consumers for device-related questions. Indicates any special storage requirements for the device. Valencia, CA 91355 The number of packages with the same Primary DI or Package DI within a given packaging configuration. Classification for devices issued by the FDA. Indicates the medical device is free from viable microorganisms. Personalizing Pain Therapy. 9. Neuromodulation Boston Scientific annually updates and provides procedural coding and reimbursement information for inpatient, outpatient, office, and ASC settings. 25155 Rye … The number that allows for the identification of a device, indicating its position within a series. Indicates that natural rubber latex was not used as materials in the manufacture of the medical product and container and the device labeling contains this information. 1. Get directions, reviews and information for Boston Scientific in Valencia, CA. The brand name is the name that is typically registered with USPTO and have the ® and/or TM symbol. SECTOR. Each patient experiences pain differently. www.HIPAASpace.com privacy policies explain how we treat your personal data and protect your privacy 5. Institute of Medicine Report from the Committee on Advancing Pain Research, Care, and Education: Relieving Pain in America, A Blueprint for Transforming Prevention, Care, Education and Research. Rechargeable and Non-rechargeable Spinal Cord Stimulators, Rechargeable and Non-rechargeable Deep Brain Stimulation Systems. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Dimension type for the clinically relevant measurement of the medical device. Company profile page for Boston Scientific Corp including stock price, company news, press releases, executives, board members, and contact information ... urology, gynecology, and neuromodulation

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