Regulatory Affairs Syndicator

The xTAG? Respiratory Viral Panel (RVP) assay is a new device that can simultaneously detect and identify nucleic acids of multiple respiratory viruses in nasopharyngeal swab specimens from individuals suspected of respiratory tract infections. Acute… (Approved: 1/3/2008)

The DexCom STS Continuous Glucose Monitoring System is a glucose sensor that reports glucose values every 5 minutes for up to 72 hours. These readings are used with fingerstick results to detect trends and patterns in glucose levels in adults with… (Approved: 3/24/2006)

The Stelkast Surpass™ Acetabular System is a ceramic on ceramic artificial hip replacement system, surgically implanted to completely replace a hip joint. (Approved: 5/12/2006)

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 precancerous cells). The doctor uses this device immediately after… (Approved: 3/16/2006)

The StarClose? Vascular Closure System (VCS) is used to close a puncture site in the femoral artery and stop bleeding following a 5 or 6 French diagnostic cardiac catheterization procedure. After a cardiac catheterization procedure it is necessary to… (Approved: 12/21/2005)

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 precancerous cells). The doctor uses this device immediately after… (Approved: 3/16/2006)

The StarClose? Vascular Closure System (VCS) is used to close a puncture site in the femoral artery and stop bleeding following a 5 or 6 French diagnostic cardiac catheterization procedure. After a cardiac catheterization procedure it is necessary to… (Approved: 12/21/2005)

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 precancerous cells). The doctor uses this device immediately after… (Approved: 3/16/2006)

The Ceralas I Laser and Ceralink Slit Lamp Adapter is a diode laser system used to activate a light sensitive (photoactivated) drug called Visudyne. This therapy may help delay vision loss in patients with an eye disorder called subfoveal choroidal …… (Approved: 12/20/2005)

The Ceralas I Laser and Ceralink Slit Lamp Adapter is a diode laser system used to activate a light sensitive (photoactivated) drug called Visudyne. This therapy may help delay vision loss in patients with an eye disorder called subfoveal choroidal …… (Approved: 12/20/2005)

The STAN® S31 Fetal Heart Monitor is 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… (Approved: 11/1/2005)

The STAN® S31 Fetal Heart Monitor is 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… (Approved: 11/1/2005)

The STAN® S31 Fetal Heart Monitor is 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… (Approved: 11/1/2005)

VISTAKON® (senofilcon A) is a soft contact lens made of approximately 38% water and 62% senofilcon A (a silicone-containing hydrogel). It is available in spherical, toric, multifocal, and multifocal-toric designs. (Approved: 12/20/2005)

VISTAKON® (senofilcon A) is a soft contact lens made of approximately 38% water and 62% senofilcon A (a silicone-containing hydrogel). It is available in spherical, toric, multifocal, and multifocal-toric designs. (Approved: 12/20/2005)