Glaukos Trabecular Micro Bypass Stent Model GTS100R/L
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L FDA PMA
- Generic Name
- Intraocular pressure lowering implant FDA PMA
Identifiers
- PMA Number
- P080030 FDA PMA
- FDA Product Code
- OGO FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Glaukos Trabecular Micro Bypass Stent Model GTS100R/L is an intraocular pressure lowering implant classified as an intraocular pressure lowering implant. It is designed as a trabecular micro-bypass stent intended to reduce intraocular pressure (IOP) in adult patients with mild to moderate open-angle glaucoma.
This device is supplied sterile and intended for use in conjunction with cataract surgery. It is a single-use implant, approved under FDA PMA (P080030), and requires surgical insertion via the provided inserter (GTS-L00I). The stent is available in two configurations, R and L, for right and left eye use, and must be stored under appropriate sterile conditions as per manufacturer instructions.
Frequently asked questions
What is the primary purpose of the Glaukos Trabecular Micro Bypass Stent Model GTS100R/L, and how is it typically used in clinical practice?
The Glaukos Trabecular Micro Bypass Stent Model GTS100R/L is designed to reduce intraocular pressure (IOP) in adult patients with mild to moderate open-angle glaucoma who are currently using ocular hypotensive medication. It is specifically intended for use during cataract surgery as an adjunct to lower IOP long-term, rather than as a standalone glaucoma treatment.
Is the stent reusable, or is it meant for single-use only? How does this affect its handling and storage?
The Glaukos Trabecular Micro Bypass Stent Model GTS100R/L is a **single-use implant**, meaning it is not intended for reuse after surgical insertion. This design ensures sterility and safety for each patient. It must be stored under sterile conditions as directed by the manufacturer, and the provided inserter (GTS-L00I) is also single-use, requiring careful handling to maintain sterility until implantation.
Are there different versions of this stent for left and right eyes? If so, how should a clinician determine which version to use?
Yes, the stent comes in two configurations: **GTS100R** for the right eye and **GTS100L** for the left eye. The choice depends on the eye being treated during surgery. The manufacturer’s labeling and packaging clearly indicate the laterality, and the surgeon should verify the correct orientation before use to ensure proper alignment during implantation.
How is the stent supplied, and what accessories are required for its surgical insertion?
The stent is supplied **sterile** and comes pre-packaged for single-use. Surgical insertion requires the use of the **GTS-L00I inserter**, which is included in the kit. The inserter is designed to facilitate precise placement of the stent during cataract surgery, ensuring proper positioning for IOP reduction.
What regulatory pathway was followed for approval of this device, and what does that mean for clinicians using it?
The Glaukos Trabecular Micro Bypass Stent Model GTS100R/L was approved under the **FDA’s Premarket Approval (PMA) pathway (PMA #P080030)**, which requires rigorous clinical evidence demonstrating safety and effectiveness. This approval confirms the device’s intended use—**reducing IOP in adult patients with mild to moderate open-angle glaucoma during cataract surgery**—and ensures it meets stringent regulatory standards before clinical use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P080030 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Glaukos Corporation
Sources (1)
- FDA PMA P080030 24 fields · synced Sep 18, 2026