Changes in suppliers for 12 critical parts, to improve the parts' quality, productivity, and delivery. The common characteristic of all 12 parts is their electrical conductivity on specified surfaces, to allow electrical continuity for proper grounding of your device. The proposed changes do not involve any changes in the design or manufacturing process of the device.
| Device | INVENIA ABUS -- AUTOMATED BREAST ULTRASOUND SYSTEM |
| Classification Name | Automated Breast Ultrasound |
| Generic Name | Automated Breast Ultrasound |
| Applicant | U-SYSTEMS, INC. |
| Date Received | 2015-09-18 |
| Decision Date | 2015-10-15 |
| PMA | P110006 |
| Supplement | S006 |
| Product Code | PAA |
| Advisory Committee | Radiology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | U-SYSTEMS, INC. 9900 West Innovative Drive mail Stop Rp2138 wauwatosa, WI 53226 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P110006 | | Original Filing |
| S010 |
2017-11-29 |
Normal 180 Day Track No User Fee |
| S009 |
2017-11-28 |
Normal 180 Day Track |
| S008 |
2017-02-28 |
Normal 180 Day Track No User Fee |
| S007 |
2016-08-03 |
Normal 180 Day Track |
| S006 |
2015-09-18 |
30-day Notice |
| S005 |
2015-02-27 |
Real-time Process |
| S004 |
2014-11-03 |
Real-time Process |
| S003 |
2014-02-26 |
30-day Notice |
| S002 |
2014-01-17 |
Real-time Process |
| S001 |
2013-03-07 |
Normal 180 Day Track |
NIH GUDID Devices