|
Device | MONOPREP PAP TEST |
Generic Name | Processor, cervical cytology slide, automated |
Applicant | HOLOGIC, INC. 250 Campus Drive Marlborough, MA 01752 |
PMA Number | P040052 |
Supplement Number | S006 |
Date Received | 01/18/2008 |
Decision Date | 07/09/2008 |
Withdrawal Date
|
03/21/2017 |
Product Code |
MKQ |
Advisory Committee |
Pathology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING CHANGES BASED ON THE ANALYSIS OF DATA FROM THE POST-MARKET STUDY ENTITLED SURE (SPECIMEN UNSAT RATE EVALUATION). THESE CHANGES HAVE BEEN INCORPORATED INTO THE LABORATORY INFORMATION AND INSTRUCTIONS LABELING. |