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. |
|
Device | INVENIA ABUS |
Generic Name | Automated breast ultrasound |
Applicant | U-SYSTEMS, INC. 9900 WEST INNOVATIVE DRIVE MAIL STOP RP2138 WAUWATOSA, WI 53226 |
PMA Number | P110006 |
Supplement Number | S003 |
Date Received | 02/26/2014 |
Decision Date | 03/20/2014 |
Product Code |
PAA |
Advisory Committee |
Radiology |
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 INCLUDE UPDATING MANUFACTURING DOCUMENTS, WORK INSTRUCTIONS, AND TEST PROCEDURES. ALSO, HIGH LEVEL ASSEMBLY OF SOME SUBCOMPONENTS WILL BE PERFORMED BY PLEXUS CORPORATION. |
|
|