|
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 |
Supplement Number | S001 |
Date Received | 03/20/2006 |
Decision Date | 04/11/2006 |
Withdrawal Date
|
11/29/2010 |
Product Code |
MWM |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement MODIFICATIONS TO THE INCOMING CAMERA INSPECTION TEST, TEST SOFTWARE USED TO ASSEMBLE THE LUMA SYSTEM AND THE FINAL TEST SOFTWARE USED DURING BURN-IN. |