Device |
intraocular pressure lowering implant |
Definition |
An intraocular pressure lowering implant is a device intended to reduce intraocular pressure when implanted in eyes which have not failed conventional medical and surgical treatment. |
Physical State |
This device category includes various materials, both biodegradable and non-biodegradable, and includes devices of various designs. |
Technical Method |
An intraocular pressure lowering implant uses various methods such as increasing aqueous outflow to reduce intraocular pressure |
Target Area |
Eye |
Review Panel |
Ophthalmic |
Product Code | OGO |
Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Ophthalmic Devices
(DHT1A)
|
Submission Type |
PMA
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standard
|
Guidance Document
|
Third Party Review |
Not Third Party Eligible |