Summary Information for: Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD)

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=H100004

Class I Medical Device Recall: CareFusion NicoletOne Software Used with CareFusion Cortical Stimulator Control Unit

<!– –> <!– Page Last Updated: 02/22/2012 –> Page Last Updated: 02/22/2012 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm292927.htm

January 2012

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Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes: P050044/S019 added

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Infants’ TYLENOL Oral Suspension, 1 oz. Grape: Recall

<!– –> <!– Page Last Updated: 02/17/2012 –> Page Last Updated: 02/17/2012 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm292566.htm

CDRH Transparency: 515 Program Initiative Status Update

<!– –> <!– Page Last Updated: 02/17/2012 –> Page Last Updated: 02/17/2012 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm240318.htm

Draft Guidance for Industry – Providing Regulatory Submissions in Electronic Format

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Public Workshop

The Food and Drug Administration (FDA) is announcing a public Workshop entitled “Design and Methodology for Postmarket Surveillance Studies under Section 522 of the Federal Food, Drug and Cosmetic Act.” This workshop is open to all interested parties, including professionals in the scientific community interested in advancing the infrastructure and methodology for postmarket surveillance studies. [...]

FDA Safety Communication: Choking Hazard and Serious Injuries with the Spinbrush line of Powered Toothbrushes

Date Issued: Feb. 16, 2012 Audience: Consumers who use or may purchase the Crest and/or Arm Hammer Spinbrush Parents and caregivers who use or may purchase the Crest and/or Arm Hammer Kid’s Spinbrush Health care professionals including dentists, dental hygienists and dental assistants who recommend the Crest and/or Arm Hammer Spinbrush Medical Specialty: Pediatrics, Dentistry [...]

Evaluation of Automatic Class III Designation (De Novo) Decision : K102333 Approval Letter added

<!– –> <!– Page Last Updated: 02/16/2012 –> Page Last Updated: 02/16/2012 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm232269.htm