Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Belgium, Brazil, Canada, Cyprus, El Salvador, Greece, Hong Kong, Israel, Mexico, Panama, Singapore, South Korea, and Thailand.
Description du dispositif
Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack. || In- Vitor Diagnostic for pH monitoring of gastric reflux || Item Number: FGS-0313 || The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry. The RAPID pH software is intended to record, store, view, and analyze gastroesophageal pH data.
“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Belgium, Brazil, Canada, Cyprus, El Salvador, Greece, Hong Kong, Israel, Mexico, Panama, Singapore, South Korea, and Thailand.
Description du dispositif
Given Imaging Bravo¿ pH capsule delivery device, 5-pack. || In-Vitro Diagnostic for pH monitoring of gastric reflux || Item Number: FGS-0312 || The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry. The RAPID pH software is intended to record, store, view, and analyze gastroesophageal pH data.