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U.S. Department of Health and Human Services

Product Classification
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Device prosthesis, breast, inflatable, internal, saline
Regulation Description Silicone inflatable breast prosthesis.
Definition Call for PMAs to be filed by 11/17/99 per 64 FR 45161 on 8/19/99
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeFWM
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Plastic and Reconstructive Surgery Devices (DHT4B)
Submission Type PMA
Regulation Number 878.3530
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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