|
Device | BD PREPSTAIN SYSTEM VACUUM PUMP SAFETY HAZARD |
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 | S023 |
Date Received | 06/27/2011 |
Decision Date | 07/15/2011 |
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 VACUUM PUMP SAFETY HAZARD LABELING CHANGES. |