|
Device | PREPSTAIN SYSTEM/PREPMATE |
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 | S024 |
Date Received | 08/24/2011 |
Decision Date | 09/21/2011 |
Product Code |
MKQ |
Advisory Committee |
Pathology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR UPDATING THE PRODUCT LABELING AND THE PREPMATE OPERATOR MANUAL. REQUESTED CHANGES TO THE PRODUCT LABELING INCLUDE UPDATING THE MET MARK, UPDATING THE MANUFACTURING ADDRESS AND EC AUTHORIZED REPRESENTATIVE NAME AND ADDRESS, ADDING CE MARK, AND ADDING BD BRANDING TO SERIAL NUMBER LABELS AND BOX LABELS. CHANGES TO THE OPERATOR MANUAL INCLUDE EDITORIAL CHANGES INTENDED TO CLARIFY AND/OR CORRECT SOME EXISTING TEXT, WHICH INCLUDED UPDATING THE COMPANY AND INSTRUMENT NAME AND BRANDING. |