FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Intraocular Pressure Lowering Implant
PMA: P080030
·
Supplement: S026
·
Decision Mar 28, 2024
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Intraocular Pressure Lowering Implant
- Trade Name
- iStent® Trabecular Mjcro-Bypass Stent System, Model GTS100
- PMA Number
- P080030
- Supplement Number
- S026
- Device Class
- FDA Class 3
- Product Code
- OGO
- Generic Name
- Intraocular pressure lowering implant
- Medical Specialty
- Unknown
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 28, 2024
- Date Received
- October 5, 2023
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Labeling Change - PAS
- Expedited Review
- N
Advisory Committee Statement
Request for approval of labeling changes made to the Directions for Use and Package Insert.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OGO | Intraocular Pressure Lowering Implant | FDA class 3 | Unknown |