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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 Device Evaluation (ODE)
Division of Surgical Devices (DSD)
Plastic and Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2)
Submission Type PMA
Regulation Number 878.3530
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Saline, Silicone Gel, and Alternative Breast Implants - Draft Guidance for Industry and FDA Staff
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible