PMA P090012S002
- Device
- MELAFIND
- Applicant
- Strata Skin Sciences, Inc.
- PMA number
- P090012
- Supplement
- S002
- Product code
- OYD
- Decision date
- 2012-10-02
- Classification
- Optical Diagnostic Device For Melanoma Detection
- Generic name
- Optical diagnostic device for melanoma detection
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- MELAFIND
- Applicant
- Strata Skin Sciences, Inc.
- PMA number
- P090012
- Supplement
- S002
- Product code
- OYD
- Generic name
- Optical diagnostic device for melanoma detection
- Decision date
- 2012-10-02
- Decision code
- APPR
- Date received
- 2012-08-13
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.