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OGO
Intraocular Pressure Lowering Implant
3
Product Code
P
17
0034
HYDRUS MICROSTENT
APPR
PMA Approval
P
17
0043
iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)
APPR
PMA Approval
P
15
0037
CyPass Micro-Stent
APPR
PMA Approval
P
08
0030
GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L
APPR
PMA Approval
P
00
0026
STAAR SURGICAL COMPANY AQUAFLOW(TM) COLLAGEN GLAUCOMA DRAINAGE DEVICE, MODEL CGDD-20
APWD
PMA Approval
QQU
Digital Therapy Device For Amblyopia
2
Product Code
HPX
Lens, Contact (Polymethylmethacrylate)
U
Product Code
LOG
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3
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3
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F
Product Code
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3
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F
Product Code
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2
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Last synced on 9 May 2025 at 11:05 pm
OP
/
OP-misc
/
OGO
/
P080030
View Source
GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L
Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
GLAUKOS, CORPORATION
Trade Name
GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L
Generic Name
Intraocular pressure lowering implant
Decision Date
6/25/2012
Days to Decision
1284 days
Decision Code
APPR
FDA Decision
Approval
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Miscellaneous
OGO
Intraocular Pressure Lowering Implant
P
17
0034
HYDRUS MICROSTENT
P
17
0043
iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)
P
15
0037
CyPass Micro-Stent
P
08
0030
GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L
P
00
0026
STAAR SURGICAL COMPANY AQUAFLOW(TM) COLLAGEN GLAUCOMA DRAINAGE DEVICE, MODEL CGDD-20
QQU
Digital Therapy Device For Amblyopia
HPX
Lens, Contact (Polymethylmethacrylate)
LOG
Catheter, Balloon For Retinal Reattachment
LOH
System, Identification, Contact Lens
LOI
Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
LQB
Medical Computers And Software For Ophthalmic Use
LQE
Implant, Corneal, Refractive
LXQ
Cup, Eye
LYX
Media, Corneal Storage
LZQ
Tissue Adhesive For Ophthalmic Use
LZR
Ultrasound, Cyclodestructive
LZS
Excimer Laser System
LZU
Plug, Punctum
MRJ
Ring, Endocapsular
MSI
Solution, Cleaning / Lubricating, Artificial Eye
MTA
Lens, Intraocular, Phakic
MUR
Graft, Sclera, Reinforcement
MWD
Electrosurgical, Radio Frequency, Refractive Correction
NBF
Prosthesis, Retinal
NCJ
Telescope, Implantable, Miniature
ODK
Refractive Corneal Implant
OKS
Lacrimal Stents And Intubation Sets
OTL
Femtosecond Laser System For Refractive Correction
OXW
Stimulator, Electrical, Transcutaneous, For Diabetic Retinopathy
PFZ
Ophthalmic Sealant
QBT
Artificial Iris
QIT
Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
QCW
Corneal Storage Media With Preservatives Including Anti-Fungal
SAX
Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
QQJ
Applicator, Negative Pressure, External, Ocular
SDE
Light Based Device For Dry Age-Related Macular Degeneration
Submissions with No Product Code
Subpart B—Diagnostic Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Therapeutic Devices
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OP
/
OP-misc
/
OGO
/
P080030
View Source
GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L
Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
GLAUKOS, CORPORATION
Trade Name
GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L
Generic Name
Intraocular pressure lowering implant
Decision Date
6/25/2012
Days to Decision
1284 days
Decision Code
APPR
FDA Decision
Approval