Author Archive for Medical Device Approvals
VISTAKON® (senofilcon A) Contact Lens
Closed Published by Medical Device Approvals January 18th, 2006 in Regulatory AffairsVISTAKON® (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)
X STOP® Interspinous Process Decompression System
Closed Published by Medical Device Approvals January 4th, 2006 in Regulatory AffairsThe X STOP ® Interspinous Process Decompression System (X STOP) is used to relieve symptoms of lumbar spinal stenosis, a narrowing of the passages for the spinal cord and nerves. (Approved: 11/21/2005)
Coaptite® is a permanently implanted device used to treat women who have stress urinary incontinence due to poorly functioning urethral sphincter muscles. The device is a tooth paste-like gel that is injected into the wall of the urethra near the bladder. (Approved: 11/10/2005)
The Visian ICL (Implantable Collamer Lens) is a lens that is permanently implanted in the eye behind the iris and in front of the natural lens. The lens is intended to correct moderate to severe nearsightedness (myopia). This type of lens is called a… (Approved: 12/22/2005)
Coaptite® is a permanently implanted device used to treat women who have stress urinary incontinence due to poorly functioning urethral sphincter muscles. The device is a tooth paste-like gel that is injected into the wall of the urethra near the bladder. (Approved: 11/10/2005)
The Visian ICL? (Implantable Collamer Lens) is a lens that is permanently implanted in the eye behind the iris and in front of the natural lens. The lens is intended to correct moderate to severe nearsightedness (myopia). This type of lens is called a… (Approved: 12/22/2005)
X STOP® Interspinous Process Decompression System
Closed Published by Medical Device Approvals January 3rd, 2006 in Regulatory AffairsThe X STOP ® Interspinous Process Decompression System (?X STOP?) is used to relieve symptoms of lumbar spinal stenosis, a narrowing of the passages for the spinal cord and nerves. (Approved: 11/21/2005)
Coaptite® is a permanently implanted device used to treat women who have stress urinary incontinence due to poorly functioning urethral sphincter muscles. The device is a tooth paste-like gel that is injected into the wall of the urethra near the bladder. (Approved: 11/10/2005)
The Visian ICL™ (Implantable Collamer Lens) is a lens that is permanently implanted in the eye behind the iris and in front of the natural lens. The lens is intended to correct moderate to severe nearsightedness (myopia). This type of lens is called a… (Approved: 12/22/2005)
X STOP® Interspinous Process Decompression System
Closed Published by Medical Device Approvals January 3rd, 2006 in Regulatory AffairsThe X STOP ® Interspinous Process Decompression System (?X STOP?) is used to relieve symptoms of lumbar spinal stenosis, a narrowing of the passages for the spinal cord and nerves. (Approved: 11/21/2005)
C2a Taper Acetabular System
Closed Published by Medical Device Approvals December 19th, 2005 in Regulatory AffairsThis device is is a ceramic on ceramic artificial hip replacement system, surgically implanted to completely replace a hip joint. (Approved: 12/16/2005)
C2a ? Taper? Acetabular System
Closed Published by Medical Device Approvals December 18th, 2005 in Regulatory AffairsThis device is is a ceramic on ceramic artificial hip replacement system, surgically implanted to completely replace a hip joint. (Approved: 12/16/2005)
C2a ? Taper™ Acetabular System
Closed Published by Medical Device Approvals December 18th, 2005 in Regulatory AffairsThis device is is a ceramic on ceramic artificial hip replacement system, surgically implanted to completely replace a hip joint. (Approved: 12/16/2005)
IBI Therapy Dual 8 Ablation Catheter and IBI 1500T6 ( USA ) Generator
Closed Published by Medical Device Approvals December 5th, 2005 in Regulatory AffairsA catheter is a flexible hollow plastic tube about the thickness of a piece of spaghetti that can be placed into a body cavity. An ablation catheter is a catheter used to destroy (ablate) abnormal tissue. (Approved: 11/18/2005)
IBI Therapy ? Dual 8 ? Ablation Catheter and IBI 1500T6 ( USA ) Generator
Closed Published by Medical Device Approvals December 5th, 2005 in Regulatory AffairsA catheter is a flexible hollow plastic tube about the thickness of a piece of spaghetti that can be placed into a body cavity. An ?ablation catheter? is a catheter used to destroy (ablate) abnormal tissue. (Approved: 11/18/2005)
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Medical Device Approvals
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