PMA P090012S009
- Device
- MELAFIND
- Applicant
- Strata Skin Sciences, Inc.
- PMA number
- P090012
- Supplement
- S009
- Product code
- OYD
- Decision date
- 2014-07-07
- Classification
- Optical Diagnostic Device For Melanoma Detection
- Generic name
- Optical diagnostic device for melanoma detection
- Approval order statement
- ADDED 3RD PARTY OPERATING SYSTEM INSTALLATION SOFTWARE TO VERSION REGISTRY; AND DEPLOYMENT OF NEW SOFTWARE BUILD AND INSTALLATION WORKSTATIONS.
Current openFDA PMA Record#
- Device
- MELAFIND
- Applicant
- Strata Skin Sciences, Inc.
- PMA number
- P090012
- Supplement
- S009
- Product code
- OYD
- Generic name
- Optical diagnostic device for melanoma detection
- Decision date
- 2014-07-07
- Decision code
- OK30
- Date received
- 2014-04-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDED 3RD PARTY OPERATING SYSTEM INSTALLATION SOFTWARE TO VERSION REGISTRY; AND DEPLOYMENT OF NEW SOFTWARE BUILD AND INSTALLATION WORKSTATIONS.