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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, testicle
Regulation Description Testicular prosthesis.
Definition Call for pmas on 7/5/95 per 60 fr 17216 on 4/5/95.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeFTO
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Urology and Lithotripsy Devices Branch (ULDB)
Submission Type PMA
Regulation Number 876.3750
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Draft Guidance for Preparation of PMA Applications for Testicular Prostheses
Third Party Review Not Third Party Eligible
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