Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | PREPSTAIN (TM) SYSTEM |
Generic Name | Processor, cervical cytology slide, automated |
Applicant | BD Diagnostic Systems 4025 STIRRUP CREEK DRIVE SUITE 400 DURHAM, NC 27703 |
PMA Number | P970018 |
Supplement Number | S006 |
Date Received | 03/24/2003 |
Decision Date | 05/02/2003 |
Product Code |
MKQ |
Advisory Committee |
Pathology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO MODIFY THE CURRENT APPROVED LABELING TO INCLUDE DATA AND INFORMATION FROM A DIRECT-TO-VIAL CLINICAL STUDY FOR HIGH GRADE SQUAMOUS INTRAEPITHELIAL AND MORE SEVERE LESIONS. |
|
|