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FDA releases November PMA approvals

January 2, 2012 by MassDevice staff

The U.S. Food & Drug Administration releases a list of pre-market approvals granted in November 2011.

Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P090012

11/1/11

MelaFind® MELA Sciences, Inc.

Irving, NY

10533

 Approval for the MelaFind device. MelaFind is intended for use on clinically atypical cutaneous pigmented lesions with one or more clinical or historical characteristics of melanoma, excluding those with a clinical diagnosis of melanoma or likely melanoma. MelaFind is designed to be used when a dermatologist chooses to obtain additional information for a decision to biopsy. MelaFind should NOT be used to confirm a clinical diagnosis of melanoma.

MelaFind is only for use by physicians trained in the clinical diagnosis and management of skin cancer (i.e., dermatologists) who have also successfully completed a training program in the

appropriate use of MelaFind.

The MelaFind result is one element of the overall clinical assessment. MelaFind positive

lesions (which may include malignant melanoma, melanoma in situ, high grade dysplastic nevi

and atypical melanocytic proliferation/hyper-plasia) should be considered for biopsy; the biopsy

decision of a MelaFind negative lesion should be based on the remainder of the entire clinical context. Lesions that are "non-evaluable" by MelaFind should be carefully re-evaluated for biopsy.

MelaFind is indicated only for use on lesions with a diameter between 2 mm and 22 mm,

lesions that are accessible by the MelaFind imager, lesions that are sufficiently pigmented (i.e. not for use on non-pigmented or skin-colored lesions), lesions that do not contain a scar or

News Well, Pre-Market Approval (PMA), Regulatory/Compliance
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