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Product Advisories | Abbott Neuromodulation
- https://www.neuromodulation.abbott/us/en/hcp/provider-resources/product-advisories.html
- St. Jude Medical Infinity™ DBS 8 Channel Lead Important Information 29 October 2018 On October 29, 2018, Abbott provided an Urgent Medical Device Recall notice to customers communicating that a …
URGENT: MEDICAL DEVICE RECALL NOTICE For 8 …
- https://www.neuromodulation.abbott/content/dam/bss/divisionalsites/nm/pdfs/guides/sjm-infinity-dbs-8-channel-lead_physician.pdf
- On October 11, 2018 Abbott began voluntarily recalling specific serial numbers associated with our 8-Channel Lead, 0.5mm spacing, for the St. Jude Medical InfinityTM DBS …
Class 2 Device Recall Eon Mini 3788 (IPG) - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112696
- ST. Jude Medical sent an important Medical Device Advisory letter dated September 4, 2012 to all affected customers. The letter identified the affected product, …
Class 2 Device Recall Eon Mini Neurostimulation Sysem
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94501
- A Product Reconciliation Form was attached to the letter for customers to complete and return any unused product to the St. Jude Medical Neuromodulation …
Product Advisories | Abbott Neuromodulation
- https://www.neuromodulation.abbott/int/en/hcp/provider-resources/product-advisories.html
- On October 29, 2018, Abbott provided an Urgent Medical Device Recall notice to customers communicating that a select number of 8-Channel Leads for the St. Jude Medical Infinity™ DBS System …
MAUDE Adverse Event Report: ST. JUDE MEDICAL
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7231237&pc=LGW
- The device is included in the neuromodulation implantable pulse generator (ipg) inaccurate elective replacement indicator advisory notice issued by abbott on (b)(6) 2017. …
St. Jude to Face Legal Action for Spinal Cord …
- https://www.legalscoops.com/st-jude-to-face-legal-action-for-spinal-cord-stimulator-implant/
- St. Jude to Face Legal Action for Spinal Cord Stimulator Implant Medical Devices February 5, 2019 By Jacob Maslow St. Jude Medical Inc. must defend part of a legal lawsuit against the …
Abbott (St Jude Medical Inc.) - 519686 - 04/12/2017 | FDA
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/abbott-st-jude-medical-inc-519686-04122017
- Between October 14 and October 26, 2016, an additional seven ICDs, also subject to this recall and in the control of St. Jude US Field Representatives, were implanted into …
MAUDE Adverse Event Report: ST. JUDE MEDICAL
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7597208&pc=LGW
- The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott …
MAUDE Adverse Event Report: ST. JUDE MEDICAL
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9789139
- ST. JUDE MEDICAL - NEUROMODULATION PRODIGY MRI IPG, 16CH, RECHARGEABLE SCS IPG Back to Search Results Model Number 3772 Device …
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