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U.S. Department of Health and Human Services

Product Classification
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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 CodeOGO
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
Third Party Review Not Third Party Eligible
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