| Final
Agenda, Final Panel Questions, Final Roster, and Briefing Information for
the Neurological Devices Panel Meeting of November 30, 2004 |
November
29, 2004 |
| Resolution
of Disputes Concerning Payment or Refund of Medical Device Uers Fees Under
MDUFMA - Guidance for Industry and FDA Staff |
November
24, 2004 |
| Summary
of the Medical Device User Fee and Modernization Act of 2002, Including
Changes Made by the Medical Devices Technical Corrections Act (April 1,
2004) |
November
23, 2004 |
| Summary
of the Medical Devices Technical Corrections Act (MDTCA) |
November
23, 2004 |
| Class
II Special Controls Guidance Document: Newborn Screening Test Systems for
Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry |
November
23, 2004 |
| Federal
Register: Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Devices; Third-Party
Review Under the Food and Drug Administration Modernization Act. |
November
19, 2004 |
| Federal
Register: Medical Devices; Revision of the Identification of the Iontophoresis
Device; Withdrawal. |
November
19, 2004 |
| Consumer
Information on: CHARITÉ(tm) Artificial Disc |
November
17, 2004 |
| Summary
Information for: Wizard X-Cell(tm) Photodynamic Therapy Balloon with Fiber
Optic Diffuser - P020021 |
November
12, 2004 |
| Summary
Information for: EVS(tm) Vascular Closure System - P040022 |
November
12, 2004 |
| Summary
Information for: Biosense Webster NaviStar(tm)/Celsius(tm) ThermoCool(r)
Diagnostic/ Ablation Deflectable Tip Catheters - P030031 |
November
12, 2004 |
| Natural
Disasters - Effects on Mammography Facilities |
November
12, 2004 |
| CDRH/CBER
MDUFMA Stakeholder Meeting Agenda - November 18, 2004 |
November
9, 2004 |
| Clinical
Trial Considerations: Vertebral Augmentation Devices to Treat Spinal Insufficiency
Fractures - Guidance for Industry and FDA Staff |
November
9, 2004 |
| Important
information regarding the supplemental validation data submissions for reprocessed
SUDs is now available on the Center for Devices and Radiological Health's
Reuse of Single Use Devices webpage |
November
9, 2004 |
| Consumer
Information on: EVS(tm) Vascular Closure System |
November
8, 2004 |
| Consumer
Information on: Philips HeartStart Home OTC Defibrillator |
November
8, 2004 |
| Status
as of November 1, 2004 of reprocessed SUDs for which supplemental validation
data were required under MDUFMA |
November
8, 2004 |
| 510(k)s
Final Decisions Rendered for October 2004 |
November
5, 2004 |
| Consumer
Information on: ExAblate(r) 2000 System |
November
3 , 2004 |
| Consumer
Information on : Syncardia Temporary CardioWest Total Artificial Heart (TAH-t) |
November
3 , 2004 |
| FDA
Warns of Dangers of Decorative Contact Lenses |
November
3 , 2004 |
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