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U.S. Department of Health and Human Services

Product Classification
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Device material, implantable for controlled release, cder or cber led
Definition Implantable material for controlled release of drug substance.
Physical State Implantable material for controlled release of drug substance.
Technical Method Implantable material for controlled release of drug substance.
Target Area Implantable material for controlled release of drug substance.
Review Panel General Hospital
Product CodeQIZ
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Not Classified Reason Unknown
Submission Type Contact ODE
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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