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. |
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Device | PREPSTAIN 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 | S012 |
Date Received | 04/19/2007 |
Decision Date | 05/09/2007 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR LABELING CHANGES FOR EXTENSION OF THE ANTIMICROBIAL EFFECTIVENESS OF THE SUREPATH PRESERVATIVE FLUID TO 14 DAYS FOR E. COLI, P. AERUGINOSA, S. AUREUS, C. ALBICANS, AND A. NIGER AND 28 DAYS FOR M. TUBERCULOSIS. |
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