MELAFIND
FDA premarket approval P090012/S009 · decided 2014-07-07
Approval details
- PMA number
- P090012
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MELAFIND
- Generic name
- Optical diagnostic device for melanoma detection
- Applicant
- Strata Skin Sciences, Inc.
- Date received
- 2014-04-29
- Decision date
- 2014-07-07
- Days to decision
- 69 days
- Decision code
- OK30
- Product code
- OYD
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Horsham, PA
- Statement
- ADDED 3RD PARTY OPERATING SYSTEM INSTALLATION SOFTWARE TO VERSION REGISTRY; AND DEPLOYMENT OF NEW SOFTWARE BUILD AND INSTALLATION WORKSTATIONS.
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