FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Intraocular Pressure Lowering Implant
PMA: P080030
·
Supplement: S019
·
Decision Dec 5, 2016
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Intraocular Pressure Lowering Implant
- Trade Name
- GLAUKOS ISTENT TRABECULAR MICRO BYPASS STENT SYSTEM
- PMA Number
- P080030
- Supplement Number
- S019
- 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 5, 2016
- Date Received
- November 7, 2016
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Modifications to the clean room and moving of the purchasing controls, receiving acceptance, and final packaging/acceptance operations to the San Clemente manufacturing site.
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 |