FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Intraocular Pressure Lowering Implant
PMA: P000026
·
Supplement: S003
·
Decision Jun 17, 2010
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Intraocular Pressure Lowering Implant
- Trade Name
- AQUAFLOW COLLAGEN GLAUCOMA DRAINAGE DEVICES
- PMA Number
- P000026
- Supplement Number
- S003
- 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
- June 17, 2010
- Date Received
- May 1, 2010
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A MINOR LABELING CHANGE FOR THE DEVICE.
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 |