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FY 2007 and 2006 ODE Annual Report - Part 1 - Advances in Patient Care

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In Fiscal Years 2006 and 2007, the Office of Device Evaluation (ODE) approved and cleared thousands of devices used to diagnose and treat a wide variety of medical conditions. Below we highlight several new medical devices and devices with new indications approved or cleared during the 2006 and 2007 fiscal years that we believe will have a particular impact on patient care.

FY 06 SECTION

Heart Devices

Image of AbioCor Implantable Replacement Heart The AbioCor® Implantable Replacement Heart, H040006, by Abiomed, Inc. was approved as a new humanitarian device exemption on September 5, 2006. The AbioCor® is an artificial replacement heart consisting of right and left blood pumps implanted in the chest. The pumps are connected to the patient's own remaining heart tissues (called the atria) and blood vessels, since the patient's own ventricles have been removed. This device may provide heart function to patients with severe heart failure. In addition, the device may have the ability to restore normal circulation as well as kidney and liver function. The AbioCor® is indicated for use in severe biventricular end stage heart disease patients who are less than 75 years old, are not cardiac transplant candidates, require multiple inotropic support, are not treatable by LVAD destination therapy, and are not weanable from biventricular support if on such support. More information can be found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=h040006.

Image of STAN S31 Fetal Heart Monitor The STAN® S31 Fetal Heart Monitor, P020001, by Neoventa Medical AB was approved on November 1, 2005. The device is a new type of fetal monitor that uses the fetal electrocardiogram (ECG) obtained through a fetal scalp electrode during labor to help the doctor or midwife decide whether to allow the mother to continue to labor or to intervene and deliver the baby. More information can be found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=P020001.

Picture of Corox OTW Steroid Lead The Tupos LV/ATx and Kronos LV-T CRT-Ds and Corox OTW Steroid Lead, P050023, by Biotronik Inc. was approved on August 10, 2006.  The Tupos LV/ATx and Kronos LV-T Cardiac Resynchronization TherapyPicture of Kronos LV-T defibrillator Defibrillator (CRT-D) Systems are implantable cardioverter defibrillators (ICDs) that also provide Cardiac Resynchronization Therapy (CRT) for patients with heart failure who need an ICD.  The CRT-D is surgically implanted below the collarbone, just beneath the skin.  One lead is placed in an upper heart chamber (the right atrium), a second lead is placed in the right lower heart chamber (ventricle), and a third lead is placed in a vein that overlies the left lower heart chamber.  When the CRT-D senses dangerous abnormal heart rhythms (arrhythmias), it shocks the heart into a normal rhythm.  The CRT coordinates the beating of the left and right ventricles so they work together to more effectively pump blood throughout the body.Picture of Tupos LV/ATx defibrillator  The Kronos LV-T CRT-D also has BIOTRONIK’s Home Monitoring technology that allows a physician to remotely monitor performance of a patient’s implanted system and condition via the Internet.  The CRT-D Systems are for use in patients who have heart failure and are at risk of sudden cardiac death.  They are indicated for use in patients who have abnormally fast heart arrhythmias (indicated for an ICD); exhibit symptoms related to heart failure; and receive optimized and stable Congestive Heart Failure (CHF) medicines.  The Tupos LV/ATx is also indicated for patients who, in addition to an indication for a CRT-D device, have atrial tachyarrhythmias or are at risk of developing atrial tachyarrhythmias.

The Corox OTW Steroid leads are intended for implantation via the coronary veins to provide long term cardiac pacing when used in conjunction with a compatible pulse generator.  More information can be found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=P050023.

 

Picture of Cordis PRECISE OTW Nitinol Stent System The Cordis PRECISE™ OTW Nitinol Stent System, P030047, by the Cordis Corporation, was approved on September 22, 2006. The device consists of a stent and delivery catheter system (PRECISE™ OTW Nitinol Stent System) and is used in conjunction with an embolic protection system (ANGIOGUARD™). The stent is a metal mesh tube on a delivery catheter, and the embolic protection device is a micromesh filter basket on the end of a delivery catheter. The ANGIOGUARD™ wire is inserted into the vessel in the groin and moved up to the blood vessel in the neck a little past the blockage. The end of the ANGIOGUARD™ opens like an umbrella. It has small holes to allow blood to flow through, but small enough to catch any pieces of debris that may break off from the blockage. After the ANGIOGUARD is opened, the physician uses the same wire to move the PRECISE stent to the blocked area. The PRECISE stent is then allowed to come out of the catheter and opens automatically over the blockage. The catheter is removed, and another catheter is put up into the neck vessel to close the ANGIOGUARD and removed, along with any pieces of debris that were trapped.

The PRECISE stent system is used in patients who have had a stroke, or who have a very tight (≥80%) blockage in the vessels of the neck. The stent is supposed to open blockages in the blood vessel in order to prevent future strokes. Stents should not be used in patients who cannot take blood thinners or who have bleeding disorders, who are allergic to nitinol, who have blockages at the beginning of the neck artery, or who have problems preventing the catheter from getting to the blockage. More information can be found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=P030047

Septal Occluders

Picture of Gore HELEX Septal Occluder The GORE HELEX™ Septal Occluder, P050006, by W.L. Gore & Associates was approved on August 11, 2006. The HELEX Septal Occluder is a minimally invasive device intended for the closure of an Atrial Septal Defects (ASDs) using cardiac catheterization. The device is made up of two parts, the delivery system and the occluder. The delivery system is a hollow catheter used to move the occluder through blood vessels to the defect in the atrial septum. The occluder is a permanent implant consisting of a circular wire frame covered with a thin GORE-TEX membrane. The wire frame is made of a nickel-titanium alloy called nitinol. More information can be found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=P050006.

 

 

 

Bone Void Fillers, Dental

Picture of GEM 21S Growth Factor Enhanced Matrix The GEM 21S (Growth Factor Enhanced Matrix), P040013, from Biomimetics Therapeutics Incorporated was approved on November 18, 2005. It is a combination of synthetic beta tricalcium phosphate particles and rhPDGF-BB, a highly purified recombinant human plate-derived growth factor. GEM 21S is indicated to treat the following periodontal related defects:
 

  • Intrabony periodontal defects;
  • Furcation periodontal defects; and,
  • Gingival recession associated with periodontal defects.

This product is the first bone filling material approved which contains a therapeutic biologic. More information can be found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=P040013

Adhesion Prevention

Picture of Adept Adhesion Reduction Solution The Adept® Adhesion Reduction Solution (4% Icodextrin), P050011, by Innovata plc was approved on July 28, 2006. This device is a pale yellow fluid that contains icodextrin. The fluid is supplied sterile, in a single-use bag. The Adept® Adhesion Reduction Solution is used in patients undergoing laparoscopic gynecological surgery (surgery on the female reproductive organs, e.g., ovaries, uterus, fallopian tubes) to reduce the number or severity of adhesions (scar tissue that binds together normally separate tissues) in the abdomen. The fluid is used during surgery and/or placed in the abdomen at the end of the surgery, to separate and protect tissues, decreasing the number of new adhesions after surgery. More information can be found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=P050011.
 

 

 

 

 

 

 

Hip Prostheses

Picture of Birmingham Hip Resurfacing System The Birmingham Hip Resurfacing (BHR) System, P040033, by Smith & Nephew Orthopaedics was approved on May 9, 2006 as a new expedited, first-of-a-kind premarket approval. The Birmingham Hip Resurfacing (BHR) System is a metal on metal resurfacing artificial hip replacement system, surgically implanted to replace a hip joint. The BHR is called a resurfacing prosthesis because only the surface of the femoral head (ball) is removed to implant the femoral head resurfacing component. The BHR system is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring future ipsilateral hip joint revision. More information can be found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=P040033.

 

Cervical Cancer

Picture of LUMA Cervical Imaging System and color map generated by the LUMA System to help a doctor decide where to biopsy cervical tissue. The LUMA™ Cervical Imaging System, P040028, by MediSpectra, Inc. was approved on March 16, 2006 as a new expedited approval. The LUMA™ Cervical Imaging System is an optical detection system that helps the doctor identify areas on the cervix that may have disease (i.e., areas that are likely to contain cancer or precancerous cells). The doctor uses the device immediately after colposcopy to decide where to take additional biopsies. The LUMA™ will help improve the chances that the doctor does not miss an area that may contain cancer or precancerous cells. More information can be found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=P040028.

Spinal Implants

Picture of X STOP Interspinous Process Decompression System The X STOP® Interspinous Process Decompression System, P040001, by St. Francis Medical Technologies, Inc. was approved on November 21, 2005. The X STOP® implant is used to relieve symptoms of lumbar spinal stenosis, a narrowing of the passages of the spinal cord and nerves. The device is a titanium implant that fits between the spinous processes of the lower (lumbar) spine. It is made of titanium alloy and consists of two components: a space assembly and a wing assembly. More information can be found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=P040001.


Loss of Smell

Picture of HealthCheck Home Test for Loss of Smell The HealthCheck™ Home Test for Loss of Smell, K051653, was cleared on March 27, 2006, via the De Novo process. The device is manufactured by MFG Inovations, Inc.

The HealthCheck™ Home Test for Loss of the Sense of Smell is packaged in a small carton which contains (1) an Instruction Book, (2) a booklet containing twelve microencapsulated smell strips, each on a separate page, with instructions for scoring the test and an Answer Key, and (3) a Physician Information Card. Each strip releases a common and easily identifiable odor when it is scratched. The user is asked to identify the odor associated with each strip by choosing an answer from one of four choices, only one of which is correct. The Answer Key at the end of the booklet indicates which odor was incorporated into each of the twelve smell strips. A user with a score of four or more incorrect answers is advised to consult with his/her physician. More information can be found at http://www.accessdata.fda.gov/cdrh_docs/pdf5/K051653.pdf.

Infection Control

Picture of INTEGUSEAL Microbial SealantINTEGUSEAL Microbial Sealant, K052870, from Kimberly-Clark Corporation was cleared on September 29, 2006 as a surgical drape accessory. INTEGUSEAL Microbial Sealant is a film-forming cyanoacrylate-based product provided in a ready-to-use applicator. The Sealant is intended to be applied on the skin over commonly used surgical skin preparation products with standard surgical draping prior to a surgical incision. Upon polymerization, INTEGUSEAL bonds to the skin, immobilizing the bacteria and thereby reducing the risk of skin flora contamination throughout a surgical procedure.

This product is one of only two products legally marketed in the USA that has been shown to reduce bacterial load from the skin during surgical procedures. More information can be found at http://www.accessdata.fda.gov/cdrh_docs/pdf5/K052870.pdf.

FY 07 SECTION

Urethral Stents

Picture showing the placement of the Spanner Temporary Prostatic Stent The Spanner™ Temporary Prostatic Stent, P060010, by AbbeyMoor Medical, Inc. was approved on December 14, 2006. This device is a sterile, disposable device, positioned in the prostatic urethra between the bladder neck and the external urinary sphincter. The Spanner™ is intended for temporary use (up to 30 days) to maintain urine flow and allow voluntary urination in patients following minimally invasive treatment for benign prostatic hyperplasia (BPH) and after initial post-treatment catheterization. The stent portion of The Spanner™ prevents obstruction of the prostatic urethra and allows urine to drain from the bladder. More information can be found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=P060010.
 

Excimer Laser

Picture of VISX STAR S4 IR Excimer Laser System The VISX STAR S4 IR™ Excimer Laser System with Variable Spot Scanning (VSS™) and WaveScan WaveFront® System, P930016/S25, by AMO/VISX, Inc. was approved on July 11, 2007. LASIK, or laser in-situ keratomileusis, is a procedure in which the surgeon cuts a flap in the outer layers of the cornea, removes a small amount of the tissue beneath it with the laser, and then replaces the flap. CustomVue Monovision LASIK produces monovision correction in nearsighted (myopic) adults, with or without astigmatism, ages 40 years or older with normal age-related loss of ability to focus on near objects (presbyopia). This is accomplished by correcting all the nearsightedness in the patient’s dominant eye (for seeing far away) and only part of the nearsightedness in the non-dominant eye (for seeing close up). CustomVue Monovision LASIK is a permanent operation to the cornea and those patients considering this procedure should first wear monovision contact lenses for at least a week to determine if they can tolerate having one eye undercorrected. More information can be found at http://www.accessdata.fda.gov/cdrh_docs/pdf/P930016s025b.pdf.


Bone Graft

The INFUSE® Bone Graft, P050053, manufactured by Medtronic Sofamor Danek was approved on March 9, 2007. This device is a bone filling material for dental use consisting of two components, a bone protein, rHBMP2 and an absorbable collagen sponge. Picture of INFUSE Bone GraftIt is an alternative to grafting a patient’s own bone. It is used to fill space where bone is needed in order to place endosseous dental implants. Endosseous dental implants are inserted in the jaw and have an exposed head that can be used to secure dental devices like a crown, fixed bridge, or dentures. INFUSE® Bone Graft is used in making enough bone in the sinus area to place endosseous dental implants in the upper jaw. It is also used to increase bone in extraction sites prior to implant placement. It can be used in situations where the patient’s own bone is not sufficient to place implants. The device eliminates the need and difficulties of grafting bone from the patient’s hip or other sites reducing the amount of pain and need for long recovery times. More information can be found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p050053.

Infants

The Olympic Cool-Cap®, P040025, by Olympic Medical Corp., was approved on December 20, Picture of Olympic Cool-Cap2006. The Olympic Cool-Cap is indicated for use in full-term infants with clinical evidence of moderate to severe hypoxic-ischemic encephalopathy (HIE). Cool-Cap provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE.   It is intended for use with infants with a birth weight of less than 1,800 grams, evidence of head trauma or skull fracture causing major intracranial bleeding or imperforate anus. More information can be found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=P040025.

Washer/ Disinfector, Infection Control

The Manzi Mach 1 Cleaner Processor System, K060458, from Langford IC Systems, Incorporated was cleared on October 12, 2006. It is a single chamber automated bronchoscope washer disinfector indicated for use with the low foaming enzyme chemical detergent MD10 and the High Level Disinfectant MS10 concentrate (MEC 0.49% PAA, minimum contact temperature of 120°F for a contact time of 15 minutes) for cleaning and high level disinfecting flexible bronchoscopes used in health care settings by health care workers. This product is the first automated washer disinfector system that uses a single chamber to automatically clean and high level disinfect bronchoscopes without the use of special connectors. More information can be found at http://www.accessdata.fda.gov/cdrh_docs/pdf6/K060458.pdf.

Respirator for General Use

In May 2007, CDRH approved the first N95 Respirators, K062070, for Use by the General Public Pictures of N95 Respiratorsin Public Health Medical Emergencies. These N95 respirators, manufactured by 3M Company were cleared via the De Novo Petition process. They are the first such devices that have been specifically evaluated and approved by FDA for use by the general public without the need for fit training and testing programs.

The FDA-approved 3M N95 Respirators for Use by the General Public in Public Health Medical Emergencies represent a significant advance in the degree of respiratory tract protection available to the general public for public health emergencies such as pandemic influenza. These respirators are required to have high filtration efficiency. They fit a wide variety of faces and provide a reasonable level of protection against aerosols of dangerous pathogens (germs), as demonstrated by testing in human subjects. Moreover, these respirators come with fit instructions so that they can be successfully used without special training or fit testing. They also have additional instructions, cautions and labeling that can help the wearer to reduce the risk of inhaling infectious airborne germs such as influenza virus. More information can be found at http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062070.pdf.

Remote Medication Management System

The INRange Remote Medication Management System, K051338, manufactured by INRange Systems, Incorporated of Altoona, PA, was cleared by the FDA on June 13, 2007 via the De Novo Petition process. Information about the device can be found at http://www.accessdata.fda.gov/cdrh_docs/pdf5/k051338.pdf.

The INRange Remote Medication Management System is composed of clinical and communications software, a medication delivery unit, and medication packaging. The system is intended for use under the supervision of a licensed healthcare practitioner to remotely deliver, manage, assess, alter dosing schedules, and/or monitor a patient’s therapeutic medication regimens and adherence to those regimens in an outpatient setting. The INRange Remote Medication Management System:

  • stores the patient's prescribed medications in a delivery unit
  • allows a healthcare professional to remotely schedule the patient's prescribed medications
  • notifies the patient when the prescribed medications are due to be taken
  • releases the prescribed medications to a tray of the delivery unit accessible to the patient on the patient's command, and
  • records a history of the event for the healthcare professional

The INRange Remote Medication Management System is used by healthcare professionals to aid in the control of the delivery of prescription drugs to patients in an outpatient setting. The medical device could help with outpatient adherence to complex medication regimens. There are no contraindications for this device.

Cervical Disc System

Picture of PRESTIGE Cervical Disc SystemThe PRESTIGE® Cervical Disc System, P060018, by Medtronic Sofamor Danek was approved on July 16, 2007. The PRESTIGE® is intended to replace a cervical disc (C3-C7) that was removed due to intractable radiculopathy and/or myelopathy (conditions that result from a disease or bulging disc). The PRESTIGE® is manufactured from stainless steel and includes superior (upper) and inferior (lower) parts that move with respect to one another by a ball and trough mechanism. The PRESTIGE® is attached to the vertebral body with stainless steel bone screws. The PRESTIGE® was the first approved cervical disc replacement and may maintain some motion at the implanted level as opposed to fusion.  More information can be found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=P060018.

 

Absorbable Suture

Picture of Tephaflex Absorbable Suture A 510(k) for Tepha, Inc.’s Tephaflex Absorbable Suture, K052225, was cleared on February 8, 2007 via the De Novo Petition process.  Tephaflex Suture is the first medical device made from a polymer purified from genetically engineered bacteria. This De Novo device will set the pathway to allow other clearances or De Novo of other recombinant DNA technology products and devices.  Premarket review included evaluation of tests described in the Surgical Suture Special Controls Guidance and FDA Guidance on recombinant DNA technology products.  In addition, data documenting chemical composition, biological purity, and pathogen inactivation were provided. 

These studies showed that the TephaFLEX Absorbable Suture can be manufactured in a consistent and safe manner with chemical, biological and mechanical properties similar to other commercially distributed surgical sutures.  The device is indicated for holding the edges of a wound together while the soft tissue heals. TephaFLEX Suture should not be used in cardiovascular, neurological or ophthalmic microsurgeries.  The device should also not be used in patients allergic to the cells or the growth media used to produce the absorbable polymeric material. More information can be found at http://www.accessdata.fda.gov/cdrh_docs/pdf5/K052225.pdf.

Aneurysms

Picture of Onyx Liquid Embolic SystemPicture of Onyx Liquid Embolic SystemThe Onyx ® Liquid Embolic System (Onyx ® HD-500), H060003, manufactured by ev3 Neurovascular, Inc. was approved on April 11, 2007. The device is an artificial material used to block blood flow into wide-neck aneurysms. The material is used to fill the aneurysm space, or pocket, and prevent the aneurysm from rupturing or increasing in size. Specifically, it is indicated for the treatment of intracranial, saccular, sidewall aneurysms that present with a wide neck (>= 4 mm) or with a dome-to-neck ratio < 2 that are not amenable to treatment with surgical clipping. These aneurysms present great difficulties for treatment since they can not be surgically corrected, nor do they have a shape that retains traditional embolic reagents, e.g., particulates, coils. The Onyx ® material is injected through a catheter into the blood vessels of the brain at the location of the aneurysm. Upon contact with blood, the material solidifies so that the flow of blood into the aneurysm is blocked, and the material remains where it is placed. The device offers hope for patients with previously considered untreatable aneurysms. More information can be found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=H060003.

Breast Implants

Picture of MemoryGel Silicone Gel-Filled Breast ImplantsThe MemoryGel Silicone Gel-Filled Breast Implants, P030053, by Mentor were approved on November 17, 2006. Each MemoryGel Silicone Gel-Filled Breast Implant consists of a single-lumen, round silicone elastomer shell, with a patch on the posterior side, which is filled with MemoryGel, Mentor’s proprietary silicone gel. The implants are available in a range of diameters, profiles (projections), and sizes, as well as in smooth and textured (Siltex) shell surfaces. The Mentor MemoryGel Silicone Gel-Filled Breast Implants are indicated for breast augmentation for women at least 22 years old, and for breast reconstruction for women of any age. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery. More information can be found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=P030053.

Picture of Inamed Silicon-Filled Breast ImplantThe Inamed® Silicone-Filled Breast Implants, P020056, by Allergan were approved on November 17, 2006. Each Inamed® Silicone-Filled Breast Implant consists of a single-lumen, round silicone elastomer shell, with a patch on the posterior side, which is filled with silicone gel. The implants are available in a range of diameters, profiles (projections), and sizes, as well as in smooth and textured (BIOCELL®) shell surfaces. The Inamed® Silicone-Filled Breast Implants are indicated for breast augmentation for women at least 22 years old and for breast reconstruction for women of any age. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery. More information can be found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=P020056.
 

Limb Salvage Shunt

Picture of Temporary Limb Salvage ShuntA 510(k) for a vascular shunt device that will help save the arms and legs of soldiers injured in combat (K070323) was cleared on February 15, 2007. This device can be implanted on the battlefield to bypass damaged blood vessels and temporarily maintain blood flow to the injured limb. Prior to this clearance, there were no devices specifically available for treating injuries of this nature. When blood flow to the injured limb can be restored until the wounded soldier can be transported to a surgical facility, the likelihood of avoiding amputation and saving the injured limb improves significantly.

The vascular shunt device, known as a Temporary Limb Salvage Shunt (TLSS), is a tube formed from two layers of plastic. The TLSS has several features that optimize the device for use in a trauma situation. These features include: (1) a self-sealing elastomer membrane that permits drugs to be injected directly into the shunt without loss of blood; (2) beveled ends that facilitate quick and effective placement of the device within the severed blood vessel; (3) graduated markings that provide visual confirmation of proper device placement; and (4) extra reinforcement in the center of the device so it can be cut to a shorter length if needed.

 

Application Activity

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 2006, ODE approved 27 PMAs and 2 HDEs; and in Fiscal Year 2007, ODE approved 27 PMAs and 2 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.

FY 06 Original PMA/HDE Approvals

  

COMPANY

DEVICE

01–Nov–05P020001Neoventa Medical ABSTAN® S31 Fetal Heart Monitor
10-Nov-05P040047Bioform Medical, Inc.Coaptite®
18-Nov-05P040042Irvine Biomedical, Inc.Therapy™ Dual 8™ Cardiac Ablation System
18-Nov-05P040013Biomimetic Pharmaceuticals, Inc.GEM 21S (Growth-factor Enhanced Matrix)
21-Nov-05P040001St. Francis Medical Technologies, Inc.X STOP® Interspinous Process Decompression System
16-Dec-05P050009Biomet Manufacturing CorporationC2a-Taper™ Acetabular System
20-Dec-05P050021QLT USA, Inc.Ceralas I Laser System and Ceralink™ Slit Lamp Adapter
20-Dec-05P040045Johnson & Johnson/ Vision Care, Inc.VISTAKON® (Senofilcon A) Contact Lenses
21-Dec-05P050007Abbott Vascular Devices (AVD)StarClose™ Vascular Closure System
22-Dec-05P030016STAAR Surgical CompanyVisian ICL™ (Implantable Collamer Lens)
16-Mar-06P040028MediSpectra, Inc.LUMA™ Cervical Imaging System
31-Mar-06H040005Karl Storz Endoscopy-America, Inc.Karl Storz Semi-Rigid TTTS Fetoscopy Instrument Set, Karl Storz Rigid TTTS Fetoscopy Instrument Set with 0 or 12 degree scope, and Karl Storz Rigid TTTS Fetoscopy Instrument Set with 30 degree scope
04-Apr-06P050026QLT USA, Inc.Quantel Activis Laser, Slit Lamp Adapters
9-May-06P040033Smith & Nephew OrthopaedicsBirmingham Hip Resurfacing (BHR) System
12-May-06P040051PaxMed Int'lStelkast Surpass™ Acetabular System
02-Jun-06P050047Inamed CorporationJucederm 24HV, 30 & 30HV
16-Jun-06P050044Orthovita, Inc.Vitagel™ Surgical Hemostat
26-Jun-06P050017Cook, Inc.Zilver® Vascular Stent
28-Jun-06P040048Zimmer, Inc.Trilogy AB Acetabular System
10-Jul-06P050014Fujifilm Medical Systems USA, Inc.Fuji Computed Radiography
28-Jul-06P050011Innovata PLCAdept® Adhesion Reduction Solution
10-Aug-06P050023Biotronik, Inc.Tupos LV/Atx CRT-D, Corox OTW
11-Aug-06P060004Carl Zeiss Meditec, Inc.MEL 80™ Excimer Laser System
11-Aug-06P050006W.L. Gore & Associates, Inc.GORE HELEX™ Septal Occluder
11-Aug-06P040036Biosense Webster, Inc.NaviStar™ ThermoCool®
14-Aug-06P050010Synthes Spine Co., L.P.PRODISC®-L Total Disc Replacement
05-Sep-06H040006Abiomed, Inc.Abiocor® Implantable Replacement Heart
22-Sep-06P030047Cordis CorporationCordis PRECISE® Nitinol Stent System
26-Sep-06P050038Medafor, Inc.Arista™ AH Absorbable Hemosat

 

FY 07 Original PMA/HDE Approvals

  

COMPANY

DEVICE

27–Oct–06P050025Endotex Interventional Systems, Inc.Endotex® Nextent® Carotid Stent
27-Oct-06P020012Artes Medical USA, Inc.ArteFill
30-Oct-06P040050Uroplasty, Inc.Macroplastique® Implants
16-Nov-06P050031Paragon Vision SciencesParagon Z CRT® Rigid Gas Permeable Contact Lenses
17-Nov-06P030053Mentor CorporationMentor MemoryGel™ Silicone Gel-Filled Breast Implants
17-Nov-06P020056AllerganInnamed® Silicone-Filled Breast Implants
14-Dec-06P060010AbbeyMoor Medical, Inc.The Spanner™ Temporary Prostatic Stent
20-Dec-06P040025Olympic Medical Corp.Olympic Cool-Cap®
20-Dec-06P050033Anika Therapeutics, Inc.Cosmetic Tissue Augmentation Product
22-Dec-06P050052BioForm Medical, Inc.Radiesse
22-Dec-06P050037BioForm Medical, Inc.Radiesse
08-Jan-07P050018AngioScore, Inc.AngioSculpt® Scoring Balloon Catheter
24-Jan-07P060001ev3, Inc.Protégé® GPS™ and Protégé® RX Carotid Stent Systems
16-Feb-07P050013Kamm & AssociatesHistoacryl® & Histoacryl® Blue Topical Skin Adhesive
09-Mar-07P050053Medtronic Sofamor Danek USA, Inc.InFuse® Bone Graft
16-Mar-07P060019Irvine Biomedical, Inc.Therapy™ Cool Path™ Ablation
11-Apr-07H060003ev3 Neurovascular, Inc.Onyx® Liquid Embolic System
13-Apr-07P050046Guidant Corp.ACUITY™ Steerable Lead
03-May-07P060011Rayner Surgical, Inc.C-flex™ Model 570C IOL
08-May-07P050004Electro Medical Systems (EMS) S.A.EMS Swiss Dolorclast®
08-May-07H060001Cordis Neurovascular, Inc.Cordis Enterprise Vascular Reconstruction Device and Delivery System
03-Jul-07P050016Corin USACormet Hip Resurfacing System
05-Jul-07P050039Exactech, Inc.Novation™ Ceramic Articulation Hip System
16-Jul-07P060018Medtronic Sofamor Danek, Inc.PRESTIGE® Cervical Disc System
23-Jul-07P060002Bard Peripheral Vascular, Inc.FLAIR™ Endovascular Stent Graft
01-Aug-07P050024CryoCor, Inc.CryoCor CryoAblation System
20-Aug-07P050043Morris Innovative Research, inc.FISH™ (Femoral Introducer Sheath and Hemostatsis Device)
07-Sep-07P040040AGA Medical Corp.Amplatzer® Muscular VSD Occl
28-Sep-07P070009Ethicon Endo-Surgery, Inc.REALIZE™ Adjustable Gastric Band


FY 06 Expedited Original and Panel Track Supplement PMA Approvals

  
COMPANY
DEVICE
21-Nov-05P040001Kyphon, Inc.X Stop Interspinous Process Decompression System
22-Dec-05P030016Staar Surgical Co.Visian ICL (Implantable Collamer Lens)
16-Mar-06P040028Medispectra, Inc.Luma Cervical Imaging System
09-May-06P040033Smith & Nephew OrthopaedicsBirmingham Hip Resurfacing (BHR) System
22-Sep-06P030047Cordis Corp.Cordis Precise Nitinol Stent System

 

FY 07 Expedited Original and Panel Track Supplement PMA Approvals

  

COMPANY

DEVICE
20-Dec-06P040025Olympic Medical CorpOlympic Cool-Cap
03-Jul-07P050016Corin U.S.A.Cormet Hip Resurfacing System
16-Jul-07P060018Medtronic Sofamor Danek, Inc.Prestige Cervical Disc System

 

De Novos Cleared In FY 06

K050939 – Cardiomems, Inc.
Cardiomems Endosensor with Delivery System – Cleared October 28, 2005

K051653 – Fmg Innovations, Inc.
Healthcheck™ Home Test for Loss of Sense of Smell - Cleared March 27, 2006

De Novos Cleared In FY 07

K060028 – Barnev, Ltd.
Computerized Labor Monitoring System – Cleared January 30, 2007

K052225 – Tepha, Inc.
Absorbable Poly-4 Hydroxydrobutyrate (P4HB) Surgical Suture – Cleared February 8, 2007

K062070 – 3M Company
3M N95 Home Respirator with Fluid Resistance; 3M N95 Home Respirator – Cleared May 8, 2007

K051338 – InRange Systems, Inc.
Remote Medication Management System – Cleared June 13, 2007

FDA Consumer Websites

Publicly Available Device Databases

The Center for Devices and Radiological Health (CDRH) maintains a website with additional consumer information about medical devices at http://www.fda.gov/MedicalDevices/ResourcesforYou/Consumers/default.htm . This website appears in a searchable format for the public .

Consumer Information

The Division of Small Manufacturers, International and Consumer Assistance (DSMICA) also provides information to consumers regarding medical devices and radiation-emitting products to enhance users ability to avoid risk, achieve maximum benefit, and make informed decisions about the use of such products.

Website: http://www.fda.gov/MedicalDevices/ResourcesforYou/Consumers/default.htm
E-Mail: dsmica@cdrh.fda.gov
Phone: Toll Free 1-800-638-2041 or 240-276-3103 directly between the hours of 8:00 a.m. – 4:30 p.m. EST
Fax: 240-276-3101
Mail: Consumer Staff, CDRH/FDA, 1350 Piccard Drive, HFZ-210, Rockville, MD 20850