PMA P040028S003
- Device
- LUMA CERVICAL IMAGING SYSTEM
- Applicant
- Spectra Science
- PMA number
- P040028
- Supplement
- S003
- Product code
- MWM
- Decision date
- 2009-02-27
- Classification
- Obstetrics/Gynecology
- Generic name
- Sensor, electro-optical (for cervical cancer)
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT SPECTRASCIENCE, INC. IN SAN DIEGO, CALIFORNIA.
Current openFDA PMA Record#
- Device
- LUMA CERVICAL IMAGING SYSTEM
- Applicant
- Spectra Science
- PMA number
- P040028
- Supplement
- S003
- Product code
- MWM
- Generic name
- Sensor, electro-optical (for cervical cancer)
- Decision date
- 2009-02-27
- Decision code
- APPR
- Date received
- 2007-12-10
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT SPECTRASCIENCE, INC. IN SAN DIEGO, CALIFORNIA.