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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, penis, inflatable
Regulation Description Penile inflatable implant.
Definition Pmas to be filed by 7/11/00 (65 fr 19658 (4/12/00)).
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeJCW
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 876.3350
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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