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Other FDA Documents - 2009 Releases
PMA Final Decisions for May 2009
 June 15, 2009
Class I Medical Device Recall: Medtronic Inc., Kappa 600/700/900 Series of Pacemakers and Sigma 100/200/300 Series of Pacemakers
 June 12, 2009
FDA News Release: FDA Alerts Patients to Medtronic Pacemaker Recall
 June 11, 2009
Gastroenterology-Urology Devices Panel Meeting - June 10, 2009 (Brief Summary)
 June 11, 2009
510(k) Final Decisions - May 2009
 June 8, 2009
Summary Information for: TAXUS Liberté Atom Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire Delivery Systems)
 June 3, 2009
PMA Final Decisions for April 2009
 June 1, 2009
Summary Information for: ARCHITECT CORE Reagent Kit, Calibrator and Controls
 May 27, 2009
Summary Information for: BRYAN Cervical Disc
 May 27, 2009
Consumer Information on: BRYAN Cervical Disc - P060023
 May 27, 2009
Circulatory System Devices Panel Advisory Meeting, April 23, 2009 - Transcript
 May 21, 2009
Neurological Devices Panel Advisory Meeting, May 14, 2009 - Slides
 May 21, 2009
Class I Medical Device Recall: Respironics, Inc., SmartMonitor 2 Infant Apnea Monitor (Models 4002 and 4003)
 May 18, 2009
Neurological Devices Panel Advisory Meeting, May 14, 2009 - Waivers for Conflicts of Interest, Agenda, Roster, Briefing, Questions
 May 12, 2009
Class I Medical Device Recall: Biosite Incorporated, Triage Cardiac Panel
 May 7, 2009
Consumer Information on: REPEL-CV Bioresorbable Adhesion Barrier - P070005
 May 7, 2009
CDRH White Oak Move
 May 4, 2009
PMA Final Decisions for March 2009
 May 1, 2009
Ophthalmic Devices Panel Advisory Meeting, March 27, 2009 - Transcript
 April 29, 2009
Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, March 31, 2009 - Transcript
 April 29, 2009
Letter of Authorization: Emergency Use of the Swine Influenza Virus Real-time RT-PCR Detection Panel
 April 28, 2009
Report to Congress: Premarket Approval of Pediatric Uses of Devices - FY 2008
 April 28, 2009
Circulatory System Devices Panel Advisory Meeting, April 23, 2009 - Agenda, Roster, Briefing, Questions, Brief Summary
 April 27, 2009
Consumer Information on: ARCHITECT CORE Reagent Kit, Calibrator and Controls - P080023
 April 17, 2009
Consumer Information on: Medtronic Attain Ability Model 4196 Lead - P080006
 April 17, 2009
Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, March 31, 2009 - Agenda, Roster, Briefing, Questions, Brief Summary, Slides
 April 17, 2009
FDA / NHLBI / NSF Workshop on Computer Methods for Cardiovascular Devices, June 1-2, 2009
 April 16, 2009
Class I Medical Device Recall: Teleflex Medical, Arrow International Inc. 30, 40, and 50 cc Intra-Aortic Balloons
 April 15, 2009
Summary Information for: Cervista HPV 16/18
 April 13, 2009
Consumer Information on: Cervista HPV 16/18 - P080015
 April 13, 2009
Consumer Information on: CervistaTM HPV HR and GenfindTM DNA Extraction Kit - P080014
 April 13, 2009
Summary Information for: CervistaTM HPV HR and GenfindTM DNA Extraction Kit
 April 13, 2009
Consumer Information on: FC2 Female Condom - P080002
 April 13, 2009
Consumer Information on: Synvisc-One (hylan GF-20) - P940015S012
 April 13, 2009
Summary Information for: Attain Ability Model 4196 Lead
 April 10, 2009
Required Submission of Safety and Effectiveness Information for Certain Class III Devices
 April 8, 2009
Class I Medical Device Recall: ZOLL Medical Corporation, ZOLL AED Plus Defibrillator
 April 8, 2009
510(k) Final Decisions - March 2009
 April 6, 2009
Class I Medical Device Recall: Tri-State Hospital Supply Corporation - Centurion Trays and Kits
 April 3, 2009
CDRH Event Problem Codes
 April 2, 2009
Medical Device Safety, Tips & Articles: Danger: "Sandbag" in the MRI Room
 April 2, 2009
Medical Device Safety, Tips & Articles: Exertion Can Disrupt Axillofemoral Bypass Grafts
 April 2, 2009
Medical Device Safety, Tips & Articles: Use Infant Heel Warmers with Care
 April 2, 2009
Obstetrics and Gynecology Devices Panel Advisory Meeting, December 13-14, 2007 - Final Minutes
 April 1, 2009
Ophthalmic Devices Panel Advisory Meeting, March 27, 2009 - Final Roster, Final Questions, Slides, Brief Summary
 April 1, 2009
PMA Final Decisions for February 2009
 April 1, 2009
Class I Medical Device Recall: Medtronic Neurologic Technologies, Innervision Snap Shunt Ventricular Catheter, BioGlide and Snap Shunt Ventricular Catheter, BioGlide
 March 27, 2009
Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, March 31, 2009 - Agenda, Roster, Briefing, Questions
 March 27, 2009
Summary Information for: FC2 Female Condom
 March 25, 2009
Circulatory System Devices Panel Advisory Meeting, March 18, 2009 - Brief Summary
 March 19, 2009
Class I Medical Device Recall: Welch Allyn AED 10 Automatic External Defibrillator (AED) and MRL JumpStart AED
 March 16, 2009
Obstetrics and Gynecology Devices Panel Advisory Meeting, December 11, 2008 - Slides
 March 12, 2009
Ophthalmic Devices Panel Advisory Meeting, March 27, 2009 - Other
 March 12, 2009
Class I Medical Device Recall: Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps
 March 11, 2009
Summary Information for: REPEL-CV Bioresorbable Adhesion Barrier
 March 11, 2009
Summary Information for: Synvisc-One
 March 10, 2009
Class I Medical Device Recall: Covidien Inc., Shiley 3.0PED Cuffless Pediatric Tracheostomy Tube
 March 9, 2009
Consumer Information on: LifeStent FlexStar and FlexStar XL Vascular Stent - P070014
 March 9, 2009
Summary Information for: LifeStent FlexStar and FlexStar XL Vascular Stent System
 March 9, 2009
Consumer Information on: NAVISTAR THERMOCOOL and EZ Steer THERMOCOOL Nav Irrigated Deflectable Diagnostic/Ablation Catheter for Treatment of Paroxysmal Atrial Fibrillation - P030031S011
 March 9, 2009
Consumer Information on: XACT Soft Acrylic UV Light-Absorbing Posterior Chamber Intraocular Lens - P080021
 March 9, 2009
510(k) Final Decisions - February 2009
 March 5, 2009
FDA Public Health Advisory - Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings
 March 5, 2009
FDA Warns About Risk of Wearing Medicated Patches During MRIs
 March 5, 2009
Consumer Information on: Reclaim DBS Therapy for OCD - H050003
 March 3, 2009
Summary Information for: Reclaim Deep Brain Stimulation for Obsessive Compulsive Disorder (OCD) Therapy
 March 3, 2009
PMA Final Decisions for January 2009
 February 25, 2009
National Registry on Safety & Atrial Fibrillation Ablation: An Incubator Thinktank (April 27-28, 2009)
 February 19, 2009
Summary Information for: Navistar ThermoCool Catheter and EZ Steer ThermoCool Catheter-Nav
 February 18, 2009
Summary Information for: XACT Foldable Hydrophobic Acrylic Ultraviolet Light-Absorbing Posterior Chamber Intraocular Lens (IOL)
 February 6, 2009
510(k) Final Decisions - January 2009
 February 5, 2009
Luer Misconnections
 February 2, 2009
Consumer Information on: TECNIS Multifocal Foldable Silicone and Acrylic Intraocular Lenses - P080010
 January 30, 2009
PMA Final Decisions for December 2008
 January 29, 2009
Consumer Information on: BIOFINITY (comfilcon A) Soft Contact Lens for Extended Wear - P080011
 January 28, 2009
Consumer Information on: Express SD Renal Monorail Premounted Stent System - P060006
 January 28, 2009
Summary Information for: BD FocalPoint GS Imaging System
 January 27, 2009
Summary Information for: COBAS AmpliPrep/COBAS TaqMan HCV Test
 January 27, 2009
Summary Information for: Tecnis Multifocal Foldable Posterior Chamber Intraocular Lenses (IOLs), Models ZM900 and ZMA00
 January 27, 2009
Obstetrics and Gynecology Devices Panel Advisory Meeting, December 11, 2008 - Transcripts
 January 23, 2009
Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, December 9, 2008 - Transcript
 January 15, 2009
FDA Unique Device Identification Public Workshop: February 12, 2009
 January 14, 2009
Immunology Devices Panel Advisory Meeting, December 3, 2008 - Transcript
 January 12, 2009
Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, November 14, 2008 - Transcript
 January 12, 2009
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Assay Migration Studies for In Vitro Diagnostic Devices; Availability
 January 12, 2009
510(k) Final Decisions - December 2008
 January 5, 2009
 
 

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