|
Device | LUMA CERVICAL IMAGING SYSTEM |
Generic Name | Sensor, electro-optical (for cervical cancer) |
Applicant | SPECTRA SCIENCE 11568 SORRENTO VALLEY RD SUITE 11 SAN DIEGO, CA 92121 |
PMA Number | P040028 |
Date Received | 06/18/2004 |
Decision Date | 03/16/2006 |
Withdrawal Date
|
11/29/2010 |
Product Code |
MWM |
Docket Number | 06M-0148 |
Notice Date | 04/12/2006 |
Advisory Committee |
Obstetrics/Gynecology |
Expedited Review Granted? | Yes |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order 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+). |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 |