FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Intraocular Pressure Lowering Implant
PMA: P080030
·
Supplement: S022
·
Decision Dec 18, 2018
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Intraocular Pressure Lowering Implant
- Trade Name
- Glaukos Corporation iStent Trabecular Micro-Bypass Stent System
- PMA Number
- P080030
- Supplement Number
- S022
- Device Class
- FDA Class 3
- Product Code
- OGO
- Generic Name
- Intraocular pressure lowering implant
- Medical Specialty
- Unknown
- Advisory Committee
- Ophthalmic
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- December 18, 2018
- Date Received
- November 21, 2018
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Changes to the heparin coating procedure and in-process drying method for the iStent Trabecular Micro-Bypass Stent System.
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 |