LUMA CERVICAL IMAGING SYSTEM
FDA premarket approval P040028 · decided 2006-03-16
Approval details
- PMA number
- P040028
- Trade name
- LUMA CERVICAL IMAGING SYSTEM
- Generic name
- Sensor, electro-optical (for cervical cancer)
- Applicant
- Spectra Science
- Date received
- 2004-06-18
- Decision date
- 2006-03-16
- Days to decision
- 636 days
- Decision code
- APWD
- Product code
- MWM
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- Yes
- Location
- San Diego, CA
- Statement
- APPROVAL FOR THE LUMA CERVICAL IMAGING SYSTEM. THE DEVICE IS INDICATED FOR USE AS AN ADJUNCT TO COLPOSCOPY FOR THE IDENTIFICATION OF HIGH-GRADE DISEASE (CIN 2, 3+) IN WOMEN REFERRED TO COLPOSCOPY WITH A PAP TEST RESULT OF ATYPICAL SQUAMOUS CELLS (ASC), LOW-GRADE SQUAMOUS INTRAEPITHELIAL LESION (LSIL) OR HIGH-GRADE SQUAMOUS INTRAEPITHELIAL LESION OR CANCER (HSIL+).
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