FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Intraocular Pressure Lowering Implant
PMA: P150037
·
Supplement: S003
·
Decision Nov 17, 2016
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Intraocular Pressure Lowering Implant
- Trade Name
- CyPass Stent
- PMA Number
- P150037
- Supplement Number
- S003
- 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
- November 17, 2016
- Date Received
- November 3, 2016
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Additional Controlled Environment Room (CER) at the approved CyPass manufacturing 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 |