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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 Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
Infection Control and 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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