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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Description Silicone gel-filled breast prosthesis.
Definition Call for pmas to be filed by 7/9/91 per 56 fr 14627 on 4/10/91
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeFTR
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
Submission Type PMA
Regulation Number 878.3540
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible