FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Intraocular Pressure Lowering Implant
PMA: P000026
·
Supplement: S002
·
Decision Mar 11, 2009
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Intraocular Pressure Lowering Implant
- Trade Name
- STAAR SURGICAL AQUAFLOW COLLAGEN GLAUCOMA DRAINAGE DEVICE
- PMA Number
- P000026
- Supplement Number
- S002
- 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
- March 11, 2009
- Date Received
- February 9, 2009
- Supplement Type
- 30-Day Notice
- Expedited Review
- N
Advisory Committee Statement
ADDITION OF A NEW REFRIGERATOR AT THE ALISO VIEJO FACILITY.
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 |