FY 2004 ODE Annual Report - Part 2 - Industry Information

Original PMA/HDE Approvals for Fiscal Year 2004
Significant Medical Device Approvals

ODE PMA/HDE Approved Devices
ODE 510(k) Clearances or Automatic Evaluations of Class III Designation Devices

ODE Guidance Documents
ODE Final Guidance Documents Adopted
ODE MDUFMA Guidance Documents Adopted
ODE Draft Guidance Documents for Comment Purposes Only

 

ODE reviews four major types of marketing applications: Premarket Notification (i.e., a 510(k) submission), Premarket Approval Application (PMA), Product Development Protocol (PDP), and Humanitarian Device Exemption (HDE). Devices cleared for marketing through the 510(k) process are too numerous to list here but can be found at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/default.htm.

During Fiscal Year 2004, 1 PDP was completed, and ODE approved 30 PMAs and 6 HDEs. These are listed below. We recommend turning to the PMA approval website, which is available at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/default.htm, for easy-to-understand one pagers for each PMA approved.

 Original PMA/HDE Approvals for Fiscal Year 2004

		COMPANY	DEVICE
01-Oct-03	P030009	Medtronic Vascular	Driver ™ Over the Wire Rapid Exchange and Multi-Exchange Coronary Stent System
07-Oct-03	P020050	SurgiVision® Refractive Consultants, LL	WaveLight ALLEGRETTO WAVE
10-Oct-03	P030008	WaveLight Laser Technologies	WaveLight Allegretto Laser for LASIK
23-Oct-03	P010059	Morcher GmbH	Morcher Capsular Tension Ring (CTR) Type: 14, 14A, 14C
24-Oct-03	P020040	Medinol Ltd.	NIRflex ™ Pre-mounted Coronary Stent
14-Nov-03	P030002	Eyeonics, Inc.	Crystalens™ (Model AT-45) Accommodating Posterior chamber (PC) Intraocular lens (IOL)
21-Nov-03	H020003	Medtronic, Inc.	Contegra® Pulmonary Valved Conduit
12-Dec-03	P020023	Q-Med Scandinavia, Inc.	Restylane ® Injectable Gel
12-Dec-03	P030039	Baxter Healthcare Corp.	CoSeal ™ Surgical Sealant
26-Jan-04	P030005	Guidant Corp.	CONTAK® RENEWAL™
04-Feb-04	P030019	Anika Therapeutics, Inc.	Orthovisc ® High Molecular Weight Hyaluronan
19-Feb-04	P030006	Celsion Corporation	Prolieve™ Thermodilation System, Transurethral Microwave Thermotherapy Device
24-Feb-04	H030004	Menssana Research, Inc.	Heartsbreath
25-Feb-04	H030003	MicroMed Technologies, Inc.	DeBakey VAD Child Ventricular Assist Device System
04-Mar-04	P030025	Boston Scientific Corp.	TAXUS™ Express 2 ™ Paclitaxel
15-Mar-04	P010058	Medilink	OSTEOSPACE™ Quantitative Ultrasound Bone Sonometer Device
07-Apr-04	H020008	Stryker Biotech	OP-1 Putty for Posterolateral Spinal Fusions
21-Apr-04	P010014	Biomet, Inc.	Oxford™ Meniscal Unicompartmental Knee System
22-Apr-04	P030032	Genzyme Corp.	Hylaform™ (Hylan B Gel)
27-Apr-04	P030017	Advanced Bionics Corp.	PRECISION™ Spinal Cord Stimulation(SCS) System
27-Apr-04	P030023	Ophtec USA, Inc.	Oculaid™ and Stableyes™ Capsular Tension Rings
30-Apr-04	P000054	Wyeth Pharmaceuiticals, Inc.	INFUSE® Bone Graft
13-May-04	P030035	St. Jude Medical	St. Jude Medical Frontier™ Biventricular Cardiac Pacing System
07-Jun-04	P010062	Euclid Systems Corp.	Euclid Systems Orthokeratology (Oprifocon A) Contact Lens
08-June-04	P030045	Ev3, Inc.	IntraStent® DoubleStrut ™ Stent
17-Jun-04	P020030	ELA Medical, Inc.	Stelid II Steroid Eluting Pacing Lead
30-Jun-04	P030054	St. Jude Medical	St. Jude Medical Epic ™ HF System
08-Jul-04	P030012	R2 Technologies, Inc.	ImageChecker® CT Lung CAD
26-Jul-04	H040002	Additional Technology	INTACS® Prescription Inserts
28-Jul-04	P010061	PhotoCure ASA	CureLight BroadBand (Model Curelight 01)
03-Aug-04	P030050	Dermik Laboratories	Sculptra
20-Aug-04	P030010	Siemens Medical Solutions USA, Inc.	Full Field Digital Mammography
24-Aug-04	H030009	Synthes ( USA )	Vertical Expandable Prosthetic Titanium Rib (VEPTR)
30-Aug-04	P040012	Guidant Corp.	ACCULINK™ & RX ACCULINK™
10-Sep-04	P030028	Ophtec USA, Inc.	ARTISAN® (Models 206 & 204) and Verisyse™ (Models VRSM5US & VRSM6US) Phakic Intraocular Lens (PIOL)
29-Sep-04	P040029	Szabocsik and Associates	JSZ Orthokeratology

 Significant Medical Device Approvals

The following devices were approved via PMAs, PMA Supplements, and HDEs or cleared via 510(k)s or classified via the Automatic Evaluation of Class III Designation process during FY 04. They represent significant medical breakthroughs because they are first-of-a-kind, e.g., they use a new technology or energy source, or they provide a major diagnostic or therapeutic advancement, such as reducing hospital stays, replacing the need for surgical intervention, reducing the time needed for a diagnostic determination, etc. The information for each device includes the trade name and/or classification name, firm, and date of approval or clearance.

 - ODE PMA/HDE Approved Devices

Division of Cardiovascular Devices (DCD) 

 DeBakey VAD Child Ventricular Assist Device System by MicroMed Technologies, Inc. ( February 25, 2004 )

Acculink Carotid Stent system and RX Acculink Carotid Stent System (First of a kind carotid stent) by Guidant Corporation ( August 30, 2004 )

Division of Ophthalmic and Ear, Nose, and Throat Devices (DOED)

Morcher Capsular Tension Ring (CTR) Type: 14, 14A and 14C by Morcher GmbH ( October 23, 2003 )

Crystalens ™ (Model AT-45) Accommodating Posterior chamber (PC) Intraocular lens (IOL) by Eyeonics Inc. ( November 14, 2003 )

Intacs Prescription Inserts for Keratoconus by Addition Technology ( July 26, 2004 )

Artisan ® (Models 206 & 204) and Verisyse ™ (Model VRSM5US &VRSM6US Phakic Intraocular Lens (PIOL) by Ophtec USA, Inc. ( September 10, 2004 )

JSZ Orthokeratology by Szabocsik and Associates ( September 29, 2004 )

Division of Reproductive, Abdominal and Radiological Devices (DRARD)

ImageChecker® CT Lung CAD by R2 Technologies, Inc. ( July 8, 2004 )

 - ODE 510(k) Clearances or Automatic Evaluations of Class III Designation Devices

DCD

Accunet™ Embolic Protection Device by Guidant Corporation ( August 31, 2004 )

DGRND

KyphX HV-R Bone Cement by Kyphon, Inc. ( April 1, 2004 )

Stryker SpinePlex by Stryker Corp. ( May 25, 2004 )

MERCI Retriever by Concentric Medical, Inc. ( August 11, 2004 )

DOED

ProKera ™ Ophthalmic Conformer by Bio-Tissue Inc. ( December 12, 2003 )

Reichert NCT (non-contact) Tonometer ( January 16, 2004 )

Zeiss Stratus OCT (optical coherence tomographer) with retinal neural layer and age-related macular degeneration database ( April 20, 2004 )

 ODE Guidance Documents

In FY 04, ODE issued 30 guidance documents, 24 final and 6 draft, which are listed below. Of the 30, 8 are related to the implementation of MDUFMA, and 11 of the 30 are Special Controls guidance. These guidance documents and other previously issued guidance documents are available on the World Wide Web (CDRH homepage: http://www.fda.gov/MedicalDevices/default.htm) which provides easy access to the latest information and operating policies and procedures. They may also be obtained from the Division of Small Manufacturers International and Consumer Assistance (DSMICA, HFZ-200). To contact DSMICA, call 800-638-2041 or 301-443-6597; fax 301-443-8818; Email dsmica@cdrh.fda.gov or write to DSMICA (HFZ-200, Food and Drug Administration, 1350 Piccard Drive , Rockville , Maryland 20850-4307 .) Many guidance documents are also available through the CDRH Facts-On-Demand (faxback service at 800-899-0381 or 301-837-0111).

 - ODE Final Guidance Documents Adopted

 - ODE MDUFMA Guidance Documents Adopted

FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Performance Assessment (October 8, 2003)

Premarket Approval Application Modular Review (November 3, 2003)

Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval Applications (November 24, 2003)

Guidance for Industry and FDA: Bundling Multiple Devices or Multiple Indications in a Single Submission (November 26, 2003)

Guidance for Industry and FDA: Expedited Review of Premarket Submissions for Devices (November 26, 2003)

Premarket Assessment of Pediatric Medical Devices (May 14, 2004)

FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment (May 21, 2004)

User Fees and Refunds for Premarket Notification Submissions (510(k)s) (May 28, 2004)

Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reproceed Single-Use Medical Devices (June1, 2004)

ODE

Premarket Approval Application Modular Review (November 3, 2003)

Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures (July 6, 2004)

Third Party Review of Premarket Notifications (September 28, 2004)

DCD

Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm (October 28, 2003)

Clinical Study Designs for Percutaneous Catheter Ablation for Treatment of Atrial Fibrillation - Guidance for Industry and FDA Staff (January 9, 2004)
Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices- Draft Guidance for Industry and FDA Staff (February 25, 2004)

DAGID

Class II Special Controls Guidance Document – Dental Sonography and Jaw Tracking Devices – Guidance for Industry and FDA Staff (December 2, 2003)

Premarket Notification [510(k)] Submissions for Chemical Indicators – Guidance for Industry and FDA Staff (December 19, 2003)

Surgical Masks – Premarket Notification [510(k)] Submissions; Guidance for Industry and FDA (March 5, 2004).

Premarket Approval Applications (PMA) for Absorbable Powder for Lubricating a Surgeon’s Glove – Guidance for Industry and FDA Staff (April 13, 2004)

Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments (May 12, 2004).

Guidance for Industry and FDA Staff – Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices (June 1, 2004)

Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Dental Noble Metal Alloys (August 23, 2004; replaced Draft dated December 1, 2003)

Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Dental Base Metal Alloys (August 23, 2004 ; replaced Draft dated December 1, 2003)

DGRND

Class II Special Controls Guidance Document: Human Dura Mater; Guidance for Industry and FDA (December 18, 2003)

Cyanoacrylate Tissue Adhesive for the Topical Approximation of Skin – Premarket Approval Applications (PMAs); Guidance for Industry and FDA (February 13, 2004)

Spinal System 510(k)s; Guidance for Industry and FDA (May 3, 2004)

DOED

Vocal Fold Medialization Devices - Premarket Notification [510(k)] Submissions - Guidance for Industry and FDA Staff (February 13, 2004)

 - ODE Draft Guidance Documents for Comment Purposes Only

Class II Special Controls Guidance Document: Dental Noble Metal Alloys (December 1, 2003)

Class II Special Controls Guidance Document: Dental Base Metal Alloys (December 1, 2003)

Saline, Silicone Gel, and Alternative Breast Implants (Level 1 draft to replace 1354 when final); Guidance for Industry and FDA (January 13, 2004)

Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices (Level 1 draft to replace 1151 when final); Guidance for Industry and FDA (February 25, 2004)

Class II Special Controls Guidance Document – External Penile Rigidity Device – Draft Guidance for Industry and FDA Staff (March 17, 2004)

Draft Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Dental Bone Grafting Material (June 30, 2004).