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 | SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM |
Generic Name | Full field digital, system, x-ray, mammographic |
Regulation Number | 892.1715 |
Applicant | GE Healthcare 3000 N. GRANDVIEW BLVD WAUKESHA, WI 53188 |
PMA Number | P990066 |
Supplement Number | S005 |
Date Received | 08/13/2001 |
Decision Date | 09/12/2001 |
Reclassified Date
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12/06/2010 |
Product Code |
MUE |
Advisory Committee |
Radiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement MANUFACTURING PROCESS CHANGE, ADDING ADDITIONAL TEST TO ONE OF THE INCOMING INSPECTION TESTS FOR THE DETECTOR. THERE WILL BE NO LABELING CHANGES OR DESIGN CHANGES TO THE SPECIFICATIONS OF THE FINISHED DEVICE. |
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