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Our Success
Premarket Notifications
• Temperature
regulation system for neuro-intensive care units [IDE and 510(k)]
• Aneurysm coils with novel configuration and coating
• Coil clot removal devices for neurointerventional use
• Femtosecond laser for use as keratome in LASIK surgery
• Selective laser trabeculoplasty for glaucoma
• Waterjet technology to replace standard blade use in
surgical applications
Premarket Applications (PMAs)
• First
permanent implant for management of gastroesophageal reflux disease
(GERD)
• Implantable polymer for bulking of the urethral sphincter in female
stress urinary incontinence
• Novel renal stent
• ImageChecker-CT System for pulmonary nodule imaging and breast imaging
• First accommodating intraocular lens
• First refractive surgery treatment for presbyopia
• Atherectomy device for cardio interventional application
• Zyoptix personalized excimer laser treatment
• First phakic intraocular lens
• Silicone oil for retinal detachment
• First “plate” design silicone intraocular lens
New Drug Applications (NDAs)
• Delivery
system for implantable, sustained release chemotherapeutic agent
for prostate cancer
• Sustained release intraocular drug delivery system for ganciclovir in
cytomegalovirus retinitis
• Synthetic immunomodulator for genital herpes simplex
and AIDS-related complex
• Drug delivery in oncology, sustained release drug
formulations
IDE Development and Submissions for Multiple Class II and III
Devices
• Adhesion
barrier device for use in laparoscopic surgery
• Temperature regulation device for neuro-intensive care unit
• Cardiac resuscitation device
• Urethral bulking agent
• Breast biopsy device
• Neurointerventional devices (coils, intracerebral stents, polymers for
embolization, clot retrieval devices) for aneurysm and stroke
• Device for lung volume reduction surgery
• Subretinal radiation therapy for age-related macular
degeneration
• Multiple new refractive surgery products and intraocular lenses
• Intrabronchial valves for COPD
IND Submissions
• Long-acting
intraocular steroid for cataract patients
• Sustained release intraocular dexamethasone drug delivery systems for
diabetic patients
• Short-interfering RNA (siRNA) for AMD, DME
• Dry-eye drug
HUD and HDE Submissions
• First
intracerebral stent for stroke prevention
• First
valve treatment for advanced
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