|
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 | S006 |
Date Received | 09/04/2001 |
Decision Date | 10/01/2001 |
Reclassified Date
|
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 ADDITION OF A SUPPLIER FOR THE COLUMN MOUNTED ON THE SENOGRAPHE 2000D SYSTEM. THERE WILL BE NO IMPACT ON THE MANUFACTURING PROCESSES (ASSEMBLY AND TESTING). THERE ARE NO LABELING CHANGES OR DESIGN CHANGES TO THE SPECIFICATIONS OF THE FINISHED DEVICE. |