Please be aware that the website you have requested is intended for the residents of a particular country or region, as noted on that site. It is used to treat acute and/or chronic intractable pain, where the use of drug therapy is undesirable or no longer effective. 1361 0 obj <>/Filter/FlateDecode/ID[<0696006BD7EE99469322B9EC7F30F385>]/Index[1336 38]/Info 1335 0 R/Length 119/Prev 1123674/Root 1337 0 R/Size 1374/Type/XRef/W[1 3 1]>>stream Explore how HF10 ® may help you find relief from chronic pain without drugs or major surgery so you can get back to enjoying life. Use only product literature from the region where the patient procedure was performed. 0 Automatisme NICE pour portail coulissant trés lourd Descriptif:. Labeling does not contain MRI Safety Information. Manuals are subject to change; the most current version is available on this page. %%EOF %PDF-1.6 %���� Analgesic spinal cord electrical stimulation system.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English, Adverse Event Without Identified Device or Use Problem (2993), Instructions for Downloading Viewers and Players. More Frequency and Waveform Versatility.
Nevro Corporation (formerly NBI Development) was founded in 2006 by Dr. Konstantinos Alataris.
It was reported to nevro that the patient acquired an infection at the ipg site. GMDN Preferred Term Name GMDN Definition; Analgesic spinal cord electrical stimulation system 23 Centimeter Band - 1240.000 to 1300.000 MHz. GMDN Names and Definitions: © Copyright GMDN Agency 2015. Brand Name: Senza® . Reproduced with Permission from the GMDN Agency. Instructions for Downloading Viewers and Players. It was reported to nevro that a patient experienced swelling over the ipg site following the implant procedure. Device was not explanted. Moteur bloquant NICE, alimentation en 230 Volts avec logique de commande incorporée, fin de course électromécanique pour portail coulissant jusqu'à 2500 kg. If you are not a health care professional, you should not enter this website. Nouvelle Mise à jour GN-2500 HD / 2500 HD NEW 1.71 02-01-2017 New update Géant GN-2500 HD / 2500 New V 1.71 Nouveau dans les mises à jour est d’améliorer le fonctionnement du serveur Internet الجديد في التحديثات هو تحسين عمل سيرفر النت Géant 2500 / 2500 HD NEW V 1.71 02-01-2017 GN-2500 HD PLUS,hd,2500 … Discover how Nevro gives you more evidence, more programming versatility, and more patient support to help your patients get back to what they love. 2 Meter Band - 144.000 to 148.000 MHz. h�b```�#�,��@(�������A�E��M�E��ð�I��Q�Q`�|�$�&F� UI&��6V�0msx��7�� Frequency Offset Tone Location Call Sponsor Notes; 144.2000: simplex : National SSB Simplex Calling Freq ... 927.2500: 902.2500: 114.8: Krell - Spokane: W7RGW: W7RGW . The manufacturing and sterilization records were reviewed, and no non-conformities were found related to the nature of the complaint. GMDN Names and Definitions: © Copyright GMDN Agency 2015. As a result, the site may contain information on medical devices and other products or uses of those products that are not approved in other countries or regions. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. Stimulator, Spinal-Cord, Totally Implanted For Pain Relief. 1 Throughout this website all referenced SCS system components including the Implantable Pulse Generator (IPG), Leads, and Accessories are a part of the Senza System. Stimulator, Spinal-Cord, Totally Implanted For Pain Relief. AccessGUDID - Senza® (00813426020015)- Senza® IPG Kit. 1.5T only) & head and extremity scans (1.5T and 3T) under specified conditions: Table 2: SENZA system components that are ONLY eligible for head and extremity MRI scans only (1.5T and 3T) with transmit/receive head or transmit/ receive local coils under specified conditions: . Nevro attempted to obtain additional information regarding the nature of the infection, but none was available. HF10 and other available SCS frequencies and waveforms are delivered by Senza Spinal Cord Stimulation (SCS) systems. GMDN Preferred Term Name GMDN Definition; Surgical implant template, single-use The reported swelling had resolved and the patient had recovered. The swelling was drained and the patient has recovered without sequelae. The device was removed and there have been no reports of further complications regarding this event.
Company Name: NEVRO CORP.. 1373 0 obj <>stream Please be aware that the website you have requested is intended for the residents of a particular country or region, as noted on that site. h�bbd```b``�"ׂH��`0�D2'�ɻ`�`�*��f��j�ق`�L~�, rn�d��b�L��z ��Dr�Ɋ���H��T�����z����L�?��;� ��g NEVRO CORP. : News, information and stories for NEVRO CORP. | Nyse: NVRO | Nyse The manufacturing record for this device was reviewed and no nonconformities were found. Omnia offers the most waveforms in a single product and can be programmed to provide waveforms independently or pair HF10 with other waveforms, enabling dual mechanisms of action that no other system can offer.
The physician stated that there was no infection and no antibiotics were given to the patient.
1336 0 obj <> endobj Device Name: Senza® IPG Kit. YOU ARE ABOUT TO ACCESS A WEBSITE INTENDED FOR THE RESIDENTS OF A PARTICULAR COUNTRY OR REGION. Nevro said it hopes to have the Senza device on the U.S. market by early 2016 if approved by the FDA. LEARN MORE. ����t���@�����\U���)�*� C��l NOTE: The official NIGP Commodity Book is copyrighted material to be used for reference purposes only and may not be reproduced without a license from Periscope Holdings, Inc. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English, Adverse Event Without Identified Device or Use Problem (2993), Instructions for Downloading Viewers and Players. Discover the Latest Nevro News, Evidence, and Events. Reproduced with Permission from the GMDN Agency. NIPG: Opn/Lnk see NIPG site . An assembly of devices that applies an electrical stimulus to all or part of the spinal cord to relieve pain (analgesia). AccessGUDID - Nevro® (00813426020282)- IPG Template Kit.
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