PMA P040028S001
- Device
- LUMA CERVICAL IMAGING SYSTEM
- Applicant
- Spectra Science
- PMA number
- P040028
- Supplement
- S001
- Product code
- MWM
- Decision date
- 2006-04-11
- Classification
- Obstetrics/Gynecology
- Generic name
- Sensor, electro-optical (for cervical cancer)
- Approval order 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.
Current openFDA PMA Record#
- Device
- LUMA CERVICAL IMAGING SYSTEM
- Applicant
- Spectra Science
- PMA number
- P040028
- Supplement
- S001
- Product code
- MWM
- Generic name
- Sensor, electro-optical (for cervical cancer)
- Decision date
- 2006-04-11
- Decision code
- OK30
- Date received
- 2006-03-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order 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.