Approval for labeling changes including: 1) deletion of the comment (outcomes of 10 pregnancies are pending as of august 2008, and outcome of one pregnancy is unknown. ) and addition of deep vein thrombosis under the section entitled other adverse events.
| Device | EXABLATE DEVICE |
| Classification Name | Ablation System, High Intensity Focused Ultrasound (hifu), Mr-guided |
| Generic Name | Ablation System, High Intensity Focused Ultrasound (hifu), Mr-guided |
| Applicant | INSIGHTEC, LTD |
| Date Received | 2012-04-09 |
| Decision Date | 2012-05-01 |
| PMA | P040003 |
| Supplement | S011 |
| Product Code | NRZ |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | INSIGHTEC, LTD 4851 Lbj Frwy, Ste 400 dallas, TX 75244 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P040003 | | Original Filing |
| S021 |
2018-04-26 |
Real-time Process |
| S020 | | |
| S019 |
2016-09-28 |
Special (immediate Track) |
| S018 |
2016-05-10 |
Real-time Process |
| S017 |
2016-04-04 |
Real-time Process |
| S016 |
2015-04-07 |
Normal 180 Day Track |
| S015 |
2015-03-04 |
Normal 180 Day Track |
| S014 |
2014-02-26 |
Normal 180 Day Track No User Fee |
| S013 |
2013-09-23 |
Real-time Process |
| S012 |
2012-08-13 |
30-day Notice |
| S011 |
2012-04-09 |
Special (immediate Track) |
| S010 |
2011-09-13 |
Normal 180 Day Track |
| S009 |
2010-07-26 |
Normal 180 Day Track No User Fee |
| S008 |
2010-07-01 |
Real-time Process |
| S007 |
2010-01-22 |
Normal 180 Day Track No User Fee |
| S006 |
2009-06-05 |
Normal 180 Day Track |
| S005 |
2008-09-19 |
Normal 180 Day Track |
| S004 |
2007-04-06 |
Normal 180 Day Track |
| S003 | | |
| S002 |
2006-07-17 |
Normal 180 Day Track |
| S001 |
2005-08-25 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices