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U.S. Department of Health and Human Services

Product Classification
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Device stent, urethral, prostatic, permanent or semi-permanent
Review Panel Gastroenterology/Urology
Product CodeMER
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry and Food and Drug Administration Staff - Guidance for the Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH)
Third Party Review Not Third Party Eligible
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