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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 Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic 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
Reporting
Ineligible
Recognized Consensus Standard
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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