BEUDAMED
    Product Code: FTR FDA class 3 21 CFR 878.3540

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    General, Plastic Surgery

    A noninflatable internal silicone gel-filled breast prosthesis is a surgically implanted device used for breast augmentation or reconstruction following mastectomy, filled with cohesive silicone gel. It is classified as FDA Class 3 (highest risk), requiring a Premarket Approval (PMA) application, reflecting its status as a permanent implant with significant safety considerations. The product code is FTR, regulated under 21 CFR 878.3540, within the General, Plastic Surgery medical specialty; a call for PMAs was issued per 56 FR 14627 on April 10, 1991. This device is designated as an implant.

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    510(k)s
    0
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    FTR
    Device Class
    FDA class 3
    Regulation Number
    878.3540
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Call for pmas to be filed by 7/9/91 per 56 fr 14627 on 4/10/91

    FEI Numbers

    This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.