LUMA CERVICAL IMAGING SYSTEM
FDA premarket approval P040028/S001 · decided 2006-04-11
Approval details
- PMA number
- P040028
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LUMA CERVICAL IMAGING SYSTEM
- Generic name
- Sensor, electro-optical (for cervical cancer)
- Applicant
- Spectra Science
- Date received
- 2006-03-20
- Decision date
- 2006-04-11
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- MWM
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- MODIFICATIONS TO THE INCOMING CAMERA INSPECTION TEST, TEST SOFTWARE USED TO ASSEMBLE THE LUMA SYSTEM AND THE FINAL TEST SOFTWARE USED DURING BURN-IN.
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