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 | S016 |
Date Received | 06/09/2009 |
Decision Date | 07/02/2009 |
Product Code |
MKQ |
Advisory Committee |
Pathology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGES TO THE METHOD OF MANUFACTURING FROM A MANUAL PROCESS TO AN AUTOMATED PROCESS TO REDUCE PRODUCTION COSTS AND IMPROVE CONTROL OF THE MANUFACTURING PROCESS. |
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