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Device
telescope, implantable, miniature
Review Panel
Ophthalmic
Product Code
NCJ
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
Eligible
Implanted Device?
Yes
Life-Sustain/Support Device?
No
Guidance Document
Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices - Guidance for Industry and Food and Drug Administration Staff
Third Party Review
Not Third Party Eligible
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