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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 [email protected] or Marina V. Kondratovich, Ph.D., at (301)796-6036 or by email at [email protected]. U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for…
October 2011
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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 Systemâ„¢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
Consumer Information on: MelaFind®
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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
Consumer Information on: Edwards SAPIEN Transcatheter Heart Valve (THV)
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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