FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Intraocular Pressure Lowering Implant
PMA: P150037
·
Supplement: S010
·
Decision Jul 23, 2018
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Intraocular Pressure Lowering Implant
- Trade Name
- CyPass Ultra System
- PMA Number
- P150037
- Supplement Number
- S010
- 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
- July 23, 2018
- Date Received
- June 25, 2018
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Addition of the Sinking Spring, PA facility as an alternative manufacturing site for the CyPass Ultra System and implement changes to the inspection test methods and acceptance criteria for the stent delivery 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 |