PMA P040028
- Device
- CERVICAL IMAGING SYSTEM
- Applicant
- Spectra Science
- PMA number
- P040028
- Supplement
- S004
- Product code
- MWM
- Decision date
- 2009-03-19
- Classification
- Obstetrics/Gynecology
- Generic name
- Sensor, electro-optical (for cervical cancer)
- Approval order statement
- APPROVAL FOR EXTENSION OF THE SHELF LIFE OF THE LUMA PROBE COVER FROM TWO YEARS TO THREE YEARS.
Current openFDA PMA Record#
- Device
- CERVICAL IMAGING SYSTEM
- Applicant
- Spectra Science
- PMA number
- P040028
- Supplement
- S004
- Product code
- MWM
- Generic name
- Sensor, electro-optical (for cervical cancer)
- Decision date
- 2009-03-19
- Decision code
- APPR
- Date received
- 2009-02-10
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR EXTENSION OF THE SHELF LIFE OF THE LUMA PROBE COVER FROM TWO YEARS TO THREE YEARS.