PMA P090012
- Device
- MELAFIND
- Applicant
- Strata Skin Sciences, Inc.
- PMA number
- P090012
- Supplement
- S011
- Product code
- OYD
- Decision date
- 2016-08-18
- Classification
- Optical Diagnostic Device For Melanoma Detection
- Generic name
- Optical diagnostic device for melanoma detection
- Approval order statement
- Approval for changing your calibration validation self-test method from the Field Phantom Imaging Self-Test to the Flap Shutter Self-Test.
Current openFDA PMA Record#
- Device
- MELAFIND
- Applicant
- Strata Skin Sciences, Inc.
- PMA number
- P090012
- Supplement
- S011
- Product code
- OYD
- Generic name
- Optical diagnostic device for melanoma detection
- Decision date
- 2016-08-18
- Decision code
- APPR
- Date received
- 2015-06-11
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changing your calibration validation self-test method from the Field Phantom Imaging Self-Test to the Flap Shutter Self-Test.