BEUDAMED
    Product Code: FWM FDA class 3 21 CFR 878.3530

    Prosthesis, Breast, Inflatable, Internal, Saline

    General, Plastic Surgery

    An inflatable internal saline breast prosthesis is a surgically implanted device used for breast augmentation or post-mastectomy reconstruction, consisting of a silicone shell filled with saline solution that can be adjusted in volume. It is classified as FDA Class 3 (highest risk), requiring Premarket Approval (PMA), given its status as a permanent implant with significant associated risks; a call for PMAs was issued per 64 FR 45161 on August 19, 1999. The product code is FWM, regulated under 21 CFR 878.3530, within the General, Plastic Surgery medical specialty. 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
    FWM
    Device Class
    FDA class 3
    Regulation Number
    878.3530
    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 11/17/99 per 64 FR 45161 on 8/19/99

    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.