PMA P040028S002
- Device
- LUMA CERVICAL IMAGING SYSTEM
- Applicant
- Spectra Science
- PMA number
- P040028
- Supplement
- S002
- Product code
- MWM
- Decision date
- 2006-06-26
- Classification
- Obstetrics/Gynecology
- Generic name
- Sensor, electro-optical (for cervical cancer)
- Approval order statement
- APPROVAL FOR TWO ADDITIONAL INTEGRITY VERIFICATION TESTS.
Current openFDA PMA Record#
- Device
- LUMA CERVICAL IMAGING SYSTEM
- Applicant
- Spectra Science
- PMA number
- P040028
- Supplement
- S002
- Product code
- MWM
- Generic name
- Sensor, electro-optical (for cervical cancer)
- Decision date
- 2006-06-26
- Decision code
- APPR
- Date received
- 2006-06-12
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR TWO ADDITIONAL INTEGRITY VERIFICATION TESTS.