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|
|MelaFind®||MELA Sciences, Inc.
|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
RECENT BLOG POSTS
SEC dings Misonix investor relations exec for insider trading
The U.S. Securities & Exchange Commission dings an outside investor relations executive for...
Boston Scientific aims to simplify intravascular imaging with Polaris
The Massachusetts medtech giant launches commercial efforts for its Polaris imaging software, an...
Boston Scientific loses bids to exclude testimony in pelvic mesh trials
A federal judge denies bids by Boston Scientific to exclude the testimony of a physician and a...
Covidien promotes Hanson to group president role | Personnel Moves
Covidien names Bryan Hanson group president, with oversight of all of the medical device company's...
Johnson & Johnson launches $5B buyback
Healthcare giant Johnson & Johnson plans to repurchase up to $5 billion of its own shares over an...
Top News Stories
Press Release: St. Jude Medical announces CE Mark approval and 1st use of the FlexAbility ablation catheter
Press Release: Boston Scientific receives FDA approval for Rebel platinum chromium coronary stent system