PMA Final Decisions for October 2011

<!– –> <!– Page Last Updated: 11/30/2011 –> Page Last Updated: 11/30/2011 <!– –> 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/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/ucm281665.htm

Guidance for Industry and Food and Drug Administration Staff

Document issued on: November 28, 2011The draft of this document was issued on September 9. 2009. For questions regarding this document contact Kate Simon, Ph.D., at (301)796-6204 or by email at kathleen.simon@fda.hhs.gov or Marina V. Kondratovich, Ph.D., at (301)796-6036 or by email at marina.kondratovich@fda.hhs.gov.  U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for [...]

October 2011

<!– –> <!– Page Last Updated: 11/22/2011 –> Page Last Updated: 11/22/2011 <!– –> 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/ucm279222.htm

Consumer Information on: NeuRx DPS?, Diaphragm Pacing System

FDA approved this device under the Humanitarian Device Exemption (HDE) program. See the links below to the Summary of Safety and Probable Benefit (SSPB) and other sites for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name: NeuRx Diaphragm Pacing System™Manufacturer: Synapse Biomedical, Inc. Address: 300 [...]

Summary Information for: NeuRx DPS?, Diaphragm Pacing System

Issued September 28, 2011 Approval Order Summary of Safety and Probable Benefit Labeling (Not Yet Available) Other Consumer Information This document is in a Portable Document Format (PDF). Acrobat Reader is required to read this document. Updated November 23, 2011 Article source: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=H100006

Consumer Information on: MelaFind®

<!– –> <!– Page Last Updated: 11/22/2011 –> Page Last Updated: 11/22/2011 <!– –> 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/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm280864.htm

Summary Information for: Edwards SAPIEN? Transcatheter Heart Valve

Issued November 2, 2011 Approval Order Summary Labeling Other Consumer Information This document is in a Portable Document Format (PDF). Acrobat Reader is required to read this document. Updated November 22, 2011 Article source: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P100041

Consumer Information on: Edwards SAPIEN Transcatheter Heart Valve (THV)

<!– –> <!– Page Last Updated: 11/22/2011 –> Page Last Updated: 11/22/2011 <!– –> 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/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm280840.htm

Consumer Information on: Belotero Balance

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Summary Information for: BELOTERO Balance

Issued November 14, 2011 Approval Order Summary Labeling Other Consumer Information This document is in a Portable Document Format (PDF). Acrobat Reader is required to read this document. Updated November 22, 2011 Article source: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P090016