PMA P090012S004

Device: MELAFIND
Applicant: Strata Skin Sciences, Inc.
PMA number: P090012
Supplement: S004
Product code: OYD
Decision date: 2015-10-22
Classification: Optical Diagnostic Device For Melanoma Detection
Generic name: Optical diagnostic device for melanoma detection
Approval order statement: APPROVAL FOR A CHANGE IN THE CART HIGH POTENTIAL (HI-POT) BREAKDOWN TEST SEQUENCE AND THE RELEASE OF HAND-HELD IMAGER HI-POT BREAKDOWN TEST PROCEDURE.

Current openFDA PMA Record#

Device: MELAFIND
Applicant: Strata Skin Sciences, Inc.
PMA number: P090012
Supplement: S004
Product code: OYD
Generic name: Optical diagnostic device for melanoma detection
Decision date: 2015-10-22
Decision code: APPR
Date received: 2014-04-29
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE IN THE CART HIGH POTENTIAL (HI-POT) BREAKDOWN TEST SEQUENCE AND THE RELEASE OF HAND-HELD IMAGER HI-POT BREAKDOWN TEST PROCEDURE.