PMA P090012S010
- Device
- MELAFIND
- Applicant
- Strata Skin Sciences, Inc.
- PMA number
- P090012
- Supplement
- S010
- Product code
- OYD
- Decision date
- 2016-03-02
- Classification
- Optical Diagnostic Device For Melanoma Detection
- Generic name
- Optical diagnostic device for melanoma detection
- Approval order statement
- Approval for labeling changes.
Current openFDA PMA Record#
- Device
- MELAFIND
- Applicant
- Strata Skin Sciences, Inc.
- PMA number
- P090012
- Supplement
- S010
- Product code
- OYD
- Generic name
- Optical diagnostic device for melanoma detection
- Decision date
- 2016-03-02
- Decision code
- APPR
- Date received
- 2014-06-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling changes.