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Consumer Information on: Hoya iSpheric™ Model YA-60BB Intraocular Lens - P080004
submitted by healthnews 697 days ago (via fda.gov)
The Hoya iSpheric™ Model YA-60BB IOL is a plastic lens used to restore vision and replace the natural lens of the eye after it is removed during cataract surgery. A cataract is a gradual thickening, hardening and clouding of the eye's lens, resulting...
 
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Class I Medical Device Recall: Medtronic INDURA 1P Intrathecal Catheter, Intrathecal Catheter, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit
submitted by healthnews 697 days ago (via fda.gov)
This recall is being conducted due to potential misconnections of the Medtronic sutureless connector (quot;SCquot;) catheters from the catheter port on the pump. These misconnections have resulted in a blockage (occlusion) between the sutureless pump connector...
 
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Maturity Health Matters: FDA Health News for Older Adults and Their Caregivers (Fall 2008 Issue)
submitted by healthnews 697 days ago (via fda.gov)
This online newsletter about FDA regulated products for older adults and their caregivers. It focuses on FDA approved products that help people live longer, more productive lives.
 
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Federal Register: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting.
submitted by healthnews 697 days ago (via fda.gov)
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices Advisory...
 
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Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recall Regulations
submitted by healthnews 697 days ago (via edocket.access.gpo.gov)
The FDA is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
 
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Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees
submitted by healthnews 697 days ago (via edocket.access.gpo.gov)
The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the agency.
 
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Federal Register: Medical Devices; Hearing Aids; Technical Data Amendments; Confirmation of Effective Date
submitted by healthnews 697 days ago (via edocket.access.gpo.gov)
The FDA is confirming the effective date of October 15, 2008, for the final rule that appeared in the Federal Register of June 2, 2008 (73 FR 31358).
 
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Summary Information for: Hoya iSpheric™ Model YA-60BB Intraocular Lens
submitted by healthnews 697 days ago (via fda.gov)
PDF format only. Topics: Intraocular Lens (IOL)
 
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CDRH Learn
submitted by healthnews 697 days ago (via fda.gov)
CDRH Learn is our latest innovative educational tool. It consists of a series of training modules describing many aspects of medical device and radiological health regulation, covering both premarket and postmarket issues...
 
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