|
Device | MONOPREP PAP TEST |
Generic Name | Processor, cervical cytology slide, automated |
Applicant | HOLOGIC, INC. 250 Campus Drive Marlborough, MA 01752 |
PMA Number | P040052 |
Date Received | 12/30/2004 |
Decision Date | 03/03/2006 |
Withdrawal Date
|
03/21/2017 |
Product Code |
MKQ |
Docket Number | 06M-0264 |
Notice Date | 06/26/2006 |
Advisory Committee |
Pathology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MONOPREP PAP TEST (MPPT). THE DEVICE IS INTENDED FOR USE IN COLLECTING AND PREPARING CERVICAL-VAGINAL CYTOLOGY SPECIMENS FOR PAP STAIN-BASED SCREENING FOR CERVICAL CANCER, IT'S PRECURSOR LESIONS, AND OTHER CYTOLOGICAL CATEGORIES AND CONDITIONS DEFINED BY THE 2001 BETHESDA SYSTEM: TERMINOLOGY FOR REPORTING RESULTS OF CERVICAL CYTOLOGY. THE MONOPREP PAP TEST PRODUCES SLIDES THAT ARE INTENDED TO REPLACE CONVENTIONALLY PREPARED PAP SMEAR SLIDES. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S004 S005 S006 S007 S008 |