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U.S. Department of Health and Human Services

Product Classification
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Device device, impotence, mechanical/hydraulic
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 CodeFHW
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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